Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy (BTSA)
Primary Purpose
Emphysema
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Endoscopic lung volume reduction
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema focused on measuring COPD, Bronchoscopic LVR, Emphysema, Hot injury
Eligibility Criteria
Inclusion Criteria:
- Age 40-75 unlimited sex. 20 subjects
- COPD, GOLD 3-4 (global obstructive lung disease).
- CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
- Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.
6 minute walking distance > 140 meters.
-
Exclusion Criteria:
- Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.
- Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
- Pulmonary hypertension> 45 mmHg, according to the Echo Test.
- . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
- Pregnancy -
Sites / Locations
- Assaf Harofeh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopic lung volume reduction
Arm Description
After usual sedation, bronchoscope is introduce to the lung and palced in segmental wedge position then hot salineis instilled. Same procedure to others affected segments.
Outcomes
Primary Outcome Measures
Pulmonary function improvemnt
Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .
Secondary Outcome Measures
Full Information
NCT ID
NCT01920321
First Posted
July 16, 2013
Last Updated
August 8, 2013
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01920321
Brief Title
Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
Acronym
BTSA
Official Title
Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.
Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an inflammatory airway and parenchymal injury and consequently fibrotic response resulting in LVR;
Detailed Description
Inclusion criteria:
Age 40-75 unlimited sex. 20 subjects
chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease).
CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
Pulmonary function tests results- total lung capacity(TLC)>110%, residual volume(RV)>150%, diffusion of lung CO(DLCO)<80%,forced expiratory volume 1 second(FEV1):15-45%.
6 minute walking distance (6MWD)> 140 meters.
Exclusion criteria:
Active ischemic heart disease, significant arrhythmia. ejection fraction (EF) <40%.
COPD that cause carbon bioxide(CO2) retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
Pulmonary hypertension> 45 mmHg, according to the Echo Test.
. Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.5. Pregnancy.
Methods: . A. Patient preparation and sedation as in diagnostic bronchoscopy. Sedation will be based on midzoln + demerol. The patients will be treated prior the treatment with Inhalation with salbutamol ans ipratropium bromide. Flexible bronchoscope with outer diameter 5 mm is introduced to the targated upper lobe, and placed in wedged position. This is followed by installion of 0.9% natriu, chloride(NaCl) at a temperature of 55ºC exit temperature 50ºC) in portions of 40 ml to 200 ml (in bronchoalveolar lavage up to 300 ml is acceptable. The patient is placed in horizontal position, and continuous ECG blood pressure. Oxygen saturation are monitored. This monitoring will be continue at least 2 hours after treatment. A chest x-ray is followed and the patient remain in the department for overnight.
Tracking: Minimum of 6 months - Outpatient follow up include in addition to physical examination extended pulmonary function test and after 3-6 months. low radiation chest CT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
COPD, Bronchoscopic LVR, Emphysema, Hot injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic lung volume reduction
Arm Type
Experimental
Arm Description
After usual sedation, bronchoscope is introduce to the lung and palced in segmental wedge position then hot salineis instilled. Same procedure to others affected segments.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic lung volume reduction
Intervention Description
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.
Primary Outcome Measure Information:
Title
Pulmonary function improvemnt
Description
Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 40-75 unlimited sex. 20 subjects
COPD, GOLD 3-4 (global obstructive lung disease).
CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.
6 minute walking distance > 140 meters.
-
Exclusion Criteria:
Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.
Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
Pulmonary hypertension> 45 mmHg, according to the Echo Test.
. Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
Pregnancy -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Stav, MD
Phone
972- 89779024
Email
dstav@asaf.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Isaac Shpirer, MD
Phone
972- 89779024
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
david Stav, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Stav, MD
12. IPD Sharing Statement
Learn more about this trial
Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
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