Back to resultsEvaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IPS System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, TLD Therapy, Targeted Lung Denervation Therapy, IPS, Innovative Pulmonary Solutions, Inc., Holaira, Inc.
Eligibility Criteria
Inclusion Criteria:
- FEV1 30% to 60%
- Patient is diagnosed with COPD
- Positive relative change in FEV1 of greater than 15%
- Patient 40 years of age or older at the time of consent
- Smoking history of at least 10 pack years
- Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study
Exclusion Criteria:
- Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
- Documented history or current evidence of congestive heart failure
- Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
- Patient has a PaCO2 > 8.0 kPa (60 mm Hg)
- Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
- Pulmonary nodule requiring surgery
- History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
- Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)
Sites / Locations
- Otto-Wagner Hospital and Medical Center
- Centre Hospitalier et Universitaire de Grenoble
- Centre Hospitalier University de Reims
- Nouvel Hopital Civil
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Targeted Lung Denervation Therapy (TLD Therapy)
Outcomes
Primary Outcome Measures
Primary Safety Endpoint
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
Secondary Outcome Measures
Performance
Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01716598
Brief Title
Evaluation of the IPS System for TLD Therapy in Patients With COPD
Acronym
IPS-II
Official Title
IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuvaira, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.
Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, TLD Therapy, Targeted Lung Denervation Therapy, IPS, Innovative Pulmonary Solutions, Inc., Holaira, Inc.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Targeted Lung Denervation Therapy (TLD Therapy)
Intervention Type
Device
Intervention Name(s)
IPS System
Other Intervention Name(s)
TLD Therapy, Targeted Lung Denervation Therapy
Intervention Description
TLD Therapy will be achieved bronchoscopically.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
Time Frame
365 Days
Secondary Outcome Measure Information:
Title
Performance
Description
Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation.
Time Frame
365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
FEV1 30% to 60%
Patient is diagnosed with COPD
Positive relative change in FEV1 of greater than 15%
Patient 40 years of age or older at the time of consent
Smoking history of at least 10 pack years
Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study
Exclusion Criteria:
Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
Documented history or current evidence of congestive heart failure
Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
Patient has a PaCO2 > 8.0 kPa (60 mm Hg)
Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
Pulmonary nodule requiring surgery
History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arschang Valipour, MD, FCCP, Ass. Prof.
Organizational Affiliation
Otto-Wagner Hospital, Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Otto-Wagner Hospital and Medical Center
City
Sanatoriumstrasse 2
State/Province
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Centre Hospitalier et Universitaire de Grenoble
City
Grenoble
Country
France
Facility Name
Centre Hospitalier University de Reims
City
Reims
Country
France
Facility Name
Nouvel Hopital Civil
City
Strasbourg
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the IPS System for TLD Therapy in Patients With COPD
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