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A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial

Primary Purpose

Emphysema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment plus Optimal Medical Therapy
Optimal Medical Therapy
Sponsored by
Uptake Medical Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Heterogeneous, Thermal Vapor, Ablation, Bronchoscopy, LVR, Lung Volume Reduction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 and ≤ 80 years old
  2. Heterogeneous emphysema with upper lobe predominance in at least one lung segment to be treated (defined as a Heterogeneity Index (HI) ≥ 1.3 per CT)
  3. Post-bronchodilator FEV1 ≥ 15% and ≤ 45% of predicted value
  4. Total lung capacity (TLC) ≥ 100% predicted
  5. Post-bronchodilator Residual volume (RV) ≥ 200% predicted
  6. 6-minute walk distance (6MWD) > 100m and ≤ 450m
  7. (Partial Pressure of Oxygen) PaCO2 ≤ 45 mm Hg; PaO2 > 45 mm Hg on room air
  8. Non-smoking for 4 months prior to study enrollment as confirmed by:

    1. negative urine analysis or serum cotinine level of ≤ 10 ng/mL, or negative CO Hb test OR
    2. If using smoking cessation product(s) containing nicotine at screening, serum cotinine level ≤ 13.7 ng/ml (or arterial carboxyhemoglobin ≤ 2.5%)
  9. Optimized medical management (consistent with GOLD guidelines)

    1. Pharmacological:

1.Long acting bronchodilator (LABA),Long-acting muscarinic antagonists (LAMA), LAMA + LABA, or LABA + ICS > 1 year

b. Evidence of completed Pulmonary Rehabilitation

  1. ≥ 6 weeks out-patient or ≥ 3 weeks in-patient within 12 months of enrollment; or,
  2. Patient has or continues to participate in at home rehabilitation program (i.e. a walking program) within 6 weeks of enrollment under the supervision of a health care professional

10. Mentally and physically able to provide written informed consent. Protected people as defined by the Code de la Sante Publique cannot be included in the study.

Exclusion Criteria:

  1. DLCO < 20% predicted
  2. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram
  3. Clinically significant bronchiectasis
  4. Clinically significant (greater than 4 tablespoons per day) sputum production.
  5. Two (2) or more COPD exacerbations or pneumonia episodes requiring hospitalization in the last year
  6. Evidence of active infection in the lungs at the time of procedure.
  7. Daily use of systemic steroids, > 10 mg prednisolone (or equivalent) daily.
  8. Lung pathology of nodule not proven stable or benign
  9. Clinically significant pulmonary fibrosis
  10. Prior lung transplant, lung volume reduction surgery (LVRS), bullectomy, or lobectomy
  11. Prior lung volume reduction via endobronchial valves(s), coil(s), and/or polymer. Note: Patients whose endobronchial valves have been removed can be treated if: all valves removed ≥ 3 months prior to InterVapor and baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation
  12. Large bulla (defined as > 1/3 volume of the lobe)
  13. Highly diseased upper and lower lobes in contralateral lung (%-950 HU density >50%)
  14. Paraseptal emphysema in any segment targeted for treatment
  15. Myocardial Infarction or congestive heart failure within 6 months of screening.
  16. Diagnosis of heart failure with Left Ventricular Ejection Fraction (LVEF) < 45% as determined by recent echocardiogram (completed within 3 months prior to screening).
  17. Unable to safely discontinue anti-coagulants or platelet inhibitors for 6 weeks post procedure.
  18. Body mass index (BMI) > 32 kg/m2
  19. Patient taking immunosuppressive drugs for the treatment of cancer, rheumatic arthritis, autoimmune disease, or prevention of tissue or organ rejection.
  20. Subject is pregnant or lactating, or plan to become pregnant within the study timeframe
  21. Any disease or condition that is likely to limit survival to less than one year
  22. Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with InterVapor®
  23. Currently enrolled in another clinical trial studying an experimental treatment.
  24. Any condition that would interfere with completion of the study including study assessments and study procedure including bronchoscopy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment plus Optimal Medical Therapy

    Optimal Medical Therapy (Control)

    Arm Description

    Patients will be treated with the InterVapor System and Optimal Medical Therapy

    Patients will be treated according to Optimal Medical Therapy

    Outcomes

    Primary Outcome Measures

    Changes in FEV1 between Treatment vs Control at 12 months
    Percentage change in Forced expiratory volume in 1 second (FEV1) compared to active comparator: Change in FEV1, percent change from baseline to 12 months in FEV1, where FEV1 is expressed in raw units of volume (mL).
    St. George's Respiratory Questionnaire for patients with Chronic Obstructive Pulmonary Disease (SGRQ-C) changes between Treatment vs Control at 12 months
    Health-related Qualify of Life (SGRQ-C) compared to active comparator. This is calculated as change from baseline to 12 months in SGRQ-C Total Score. SGRQ-C scores range from 0 to 100. A higher score means a worse outcome.

    Secondary Outcome Measures

    Improvement in other measures of pulmonary function- Forced Expiratory Volume, absolute change- at 12, 18 and 24 months
    Change in FEV1, abs: Absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in raw units of volume (mL).
    Improvement in other measures of pulmonary function- Forced Expiratory Volume, Percent change- at 12, 18 and 24 months
    Change in FEV1, Percent Predicted value: Percent change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by European Respiratory Standard (ERS) standards.
    Improvement in other measures of pulmonary function- Forced Expiratory Volume, Abs, PP change- at 12, 18 and 24 months
    Change in FEV1, abs, PP: absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by ERS standards.
    Improvement in other measures of pulmonary function- Forced Vital Capacity(FVC) change- at 12, 18 and 24 months
    Change in FVC: percent change from baseline to follow-up in Forced Vital Capacity, expressed in raw units of volume(mL)
    Improvement in other measures of pulmonary function- Forced Vital Capacity Percent Predicted change- at 12, 18 and 24 months
    Change in FVC PP: percent change from baseline to follow-up in Forced Vital Capacity, expressed in percent predicted computed by ERS standards
    Improvement in other measures of pulmonary function- Residual Volume- at 12, 18 and 24 months
    Percent change from baseline to follow-up in Residual Volume
    Improvement in other measures of pulmonary function- Residual Volume-Abs at 12, 18 and 24 months
    Percent change from baseline to follow-up in Residual Volume, where RV is expressed in raw units of volume (mL).
    Improvement in other measures of pulmonary function- Residual Volume-Percent Predicted value at 12, 18 and 24 months
    Percent change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards.
    Improvement in other measures of pulmonary function- Residual Volume-Abs Percent Predicted value at 12, 18 and 24 months
    Absolute change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards
    Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Percent Predicted Value at 12, 18 and 24 months
    Percent change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards.
    Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Absolute Percent Predicted Value at 12, 18 and 24 months
    Absolute change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards.
    Changes in segmental lung volumes from as assessed by CT at 12, 18 and 24 months
    Changes in segmental lung volumes from baseline to 12 months as assessed by CT
    Changes in pulmonary function tests as assessed by body plethysmography measures at 12, 18 and 24 months
    Changes in pulmonary function tests as assessed by body plethysmography measures at 12 months
    Number of serious adverse events and fatal events
    Number of serious adverse events (SAEs) and fatal events
    Binary responder analysis to determine minimally clinical important difference for FEV1 at 12, 18 and 24 months
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • FEV1 (> 12% predicted) in Treatment vs Control at 12 months
    Binary responder analysis to determine minimally clinical important difference for SGRQ-C at 12, 18 and 24 months
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • SGRQ (> 8 points) in Treatment vs Control at 12 months
    Binary responder analysis to determine minimally clinical important difference for 6 Minute Walk Distance (6MWD) at 12, 18 and 24 months
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • 6MWD (> 26m) in Treatment vs Control at 12 months
    Binary responder analysis to determine minimally clinical important difference for COPD Assessment Test (CAT) score at 12, 18 and 24 months
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • CAT Score (> 2 points) in Treatment vs Control at 12 months
    Binary responder analysis to determine minimally clinical important difference for Shortness of Breath Questionnaire (SOBQ) score at 12, 18 and 24 months
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • SOBQ Score (> 5 points) in Treatment vs Control at 12 month

    Full Information

    First Posted
    July 8, 2020
    Last Updated
    July 28, 2023
    Sponsor
    Uptake Medical Technology, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05118269
    Brief Title
    A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
    Official Title
    Targeted Segmental Vapor Ablation Treatment of Emphysema With Upper Lobe Predominance: A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uptake Medical Technology, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
    Detailed Description
    The primary objectives are to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with Bronchoscopic Thermal Vapor Ablation (BTVA) using the InterVapor system in patients with heterogeneous emphysema with upper lobe predominance. The French TARGET trial is a prospective, multi-center, single blind, randomized controlled study. 150 participants will be enrolled in the study (1:1 randomization with 75 InterVapor, 75 controls) with a 24-month follow-up period. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment once they have completed the protocol defined 12-month follow-up period.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Emphysema
    Keywords
    Heterogeneous, Thermal Vapor, Ablation, Bronchoscopy, LVR, Lung Volume Reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Subjects will be randomized in a 1:1 ratio between treatment group and control group. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment at 12 months, once they have completed the protocol defined follow-up period.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment plus Optimal Medical Therapy
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with the InterVapor System and Optimal Medical Therapy
    Arm Title
    Optimal Medical Therapy (Control)
    Arm Type
    Active Comparator
    Arm Description
    Patients will be treated according to Optimal Medical Therapy
    Intervention Type
    Device
    Intervention Name(s)
    Treatment plus Optimal Medical Therapy
    Other Intervention Name(s)
    InterVapor, BTVA
    Intervention Description
    Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/World Health Organization , Global Initiative for Chronic Obstructive Lung Disease (GOLD) workshop summary).
    Intervention Type
    Other
    Intervention Name(s)
    Optimal Medical Therapy
    Intervention Description
    Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
    Primary Outcome Measure Information:
    Title
    Changes in FEV1 between Treatment vs Control at 12 months
    Description
    Percentage change in Forced expiratory volume in 1 second (FEV1) compared to active comparator: Change in FEV1, percent change from baseline to 12 months in FEV1, where FEV1 is expressed in raw units of volume (mL).
    Time Frame
    12 months
    Title
    St. George's Respiratory Questionnaire for patients with Chronic Obstructive Pulmonary Disease (SGRQ-C) changes between Treatment vs Control at 12 months
    Description
    Health-related Qualify of Life (SGRQ-C) compared to active comparator. This is calculated as change from baseline to 12 months in SGRQ-C Total Score. SGRQ-C scores range from 0 to 100. A higher score means a worse outcome.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Improvement in other measures of pulmonary function- Forced Expiratory Volume, absolute change- at 12, 18 and 24 months
    Description
    Change in FEV1, abs: Absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in raw units of volume (mL).
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Forced Expiratory Volume, Percent change- at 12, 18 and 24 months
    Description
    Change in FEV1, Percent Predicted value: Percent change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by European Respiratory Standard (ERS) standards.
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Forced Expiratory Volume, Abs, PP change- at 12, 18 and 24 months
    Description
    Change in FEV1, abs, PP: absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by ERS standards.
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Forced Vital Capacity(FVC) change- at 12, 18 and 24 months
    Description
    Change in FVC: percent change from baseline to follow-up in Forced Vital Capacity, expressed in raw units of volume(mL)
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Forced Vital Capacity Percent Predicted change- at 12, 18 and 24 months
    Description
    Change in FVC PP: percent change from baseline to follow-up in Forced Vital Capacity, expressed in percent predicted computed by ERS standards
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Residual Volume- at 12, 18 and 24 months
    Description
    Percent change from baseline to follow-up in Residual Volume
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Residual Volume-Abs at 12, 18 and 24 months
    Description
    Percent change from baseline to follow-up in Residual Volume, where RV is expressed in raw units of volume (mL).
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Residual Volume-Percent Predicted value at 12, 18 and 24 months
    Description
    Percent change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards.
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function- Residual Volume-Abs Percent Predicted value at 12, 18 and 24 months
    Description
    Absolute change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Percent Predicted Value at 12, 18 and 24 months
    Description
    Percent change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards.
    Time Frame
    12 months, 18 months, 24 months
    Title
    Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Absolute Percent Predicted Value at 12, 18 and 24 months
    Description
    Absolute change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards.
    Time Frame
    12 months, 18 months, 24 months
    Title
    Changes in segmental lung volumes from as assessed by CT at 12, 18 and 24 months
    Description
    Changes in segmental lung volumes from baseline to 12 months as assessed by CT
    Time Frame
    12 months, 18 months, 24 months
    Title
    Changes in pulmonary function tests as assessed by body plethysmography measures at 12, 18 and 24 months
    Description
    Changes in pulmonary function tests as assessed by body plethysmography measures at 12 months
    Time Frame
    12 months, 18 months, 24 months
    Title
    Number of serious adverse events and fatal events
    Description
    Number of serious adverse events (SAEs) and fatal events
    Time Frame
    12 months, 18 months, 24 months
    Title
    Binary responder analysis to determine minimally clinical important difference for FEV1 at 12, 18 and 24 months
    Description
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • FEV1 (> 12% predicted) in Treatment vs Control at 12 months
    Time Frame
    12 months, 18 months, 24 months
    Title
    Binary responder analysis to determine minimally clinical important difference for SGRQ-C at 12, 18 and 24 months
    Description
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • SGRQ (> 8 points) in Treatment vs Control at 12 months
    Time Frame
    12 months, 18 months, 24 months
    Title
    Binary responder analysis to determine minimally clinical important difference for 6 Minute Walk Distance (6MWD) at 12, 18 and 24 months
    Description
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • 6MWD (> 26m) in Treatment vs Control at 12 months
    Time Frame
    12 months, 18 months, 24 months
    Title
    Binary responder analysis to determine minimally clinical important difference for COPD Assessment Test (CAT) score at 12, 18 and 24 months
    Description
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • CAT Score (> 2 points) in Treatment vs Control at 12 months
    Time Frame
    12 months, 18 months, 24 months
    Title
    Binary responder analysis to determine minimally clinical important difference for Shortness of Breath Questionnaire (SOBQ) score at 12, 18 and 24 months
    Description
    Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • SOBQ Score (> 5 points) in Treatment vs Control at 12 month
    Time Frame
    12 months, 18 months, 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 and ≤ 80 years old Heterogeneous emphysema with upper lobe predominance in at least one lung segment to be treated (defined as a Heterogeneity Index (HI) ≥ 1.2 per CT) Post-bronchodilator FEV1 ≥ 15% and ≤ 45% of predicted value Total lung capacity (TLC) ≥ 100% predicted Post-bronchodilator Residual volume (RV) ≥ 200% predicted 6-minute walk distance (6MWD) > 100m and ≤ 450m (Partial Pressure of Oxygen) PaCO2 ≤ 45 mm Hg; PaO2 > 45 mm Hg on room air Non-smoking for 4 months prior to study enrollment as confirmed by: negative urine analysis or serum cotinine level of ≤ 10 ng/mL, or negative CO Hb test OR If using smoking cessation product(s) containing nicotine at screening, serum cotinine level ≤ 13.7 ng/ml (or arterial carboxyhemoglobin ≤ 2.5%) Optimized medical management (consistent with GOLD guidelines) Pharmacological: 1.Long acting bronchodilator (LABA),Long-acting muscarinic antagonists (LAMA), LAMA + LABA, or LABA + ICS > 1 year b. Evidence of completed Pulmonary Rehabilitation ≥ 6 weeks out-patient or ≥ 3 weeks in-patient within 12 months of enrollment; or, Patient has or continues to participate in at home rehabilitation program (i.e. a walking program) within 6 weeks of enrollment under the supervision of a health care professional 10. Mentally and physically able to provide written informed consent to participate in the study. Protected people as defined by the Code de la Sante Publique cannot be included in the study Exclusion Criteria: DLCO < 20% predicted Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure >45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram Clinically significant bronchiectasis Clinically significant (greater than 4 tablespoons per day) sputum production. Two (2) or more COPD exacerbations or pneumonia episodes requiring hospitalization in the last year Evidence of active infection in the lungs at the time of procedure. Daily use of systemic steroids, > 10 mg prednisolone (or equivalent) daily. Lung pathology of nodule not proven stable or benign Clinically significant pulmonary fibrosis Prior lung transplant, lung volume reduction surgery (LVRS), bullectomy, or lobectomy Prior lung volume reduction via endobronchial valves(s), coil(s), and/or polymer. Note: Patients whose endobronchial valves have been removed can be treated if: all valves removed ≥ 3 months prior to InterVapor and baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation Large bulla (defined as > 1/3 volume of the lobe) Highly diseased upper and lower lobes in contralateral lung (%-950 HU density >50%) Paraseptal emphysema in any segment targeted for treatment Myocardial Infarction or congestive heart failure within 6 months of screening. Diagnosis of heart failure with Left Ventricular Ejection Fraction (LVEF) < 45% as determined by recent echocardiogram (completed within 3 months prior to screening). Unable to safely discontinue anti-coagulants or platelet inhibitors for 6 weeks post procedure. Body mass index (BMI) > 32 kg/m2 Patient taking immunosuppressive drugs for the treatment of cancer, rheumatic arthritis, autoimmune disease, or prevention of tissue or organ rejection. Subject is pregnant or lactating, or plan to become pregnant within the study timeframe Any disease or condition that is likely to limit survival to less than one year Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with InterVapor® Currently enrolled in another clinical trial studying an experimental treatment. Any condition that would interfere with completion of the study including study assessments and study procedure including bronchoscopy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Idris
    Phone
    +1-408-391-0098
    Email
    jidris@broncus.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicolas Guibert, Prof
    Organizational Affiliation
    CHU Toulouse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial

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