Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy

Emphysema Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01920321
• Other study ID #: 195/12
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 16, 2013
• Last updated: August 8, 2013
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Assaf-Harofeh Medical Center
• Contact: David Stav, MD
• Phone: 972- 89779024
• Email: dstav[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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;

Description:

Inclusion criteria:

1. Age 40-75 unlimited sex. 20 subjects

2. chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease).

3. CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.

4. 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%.

5. 6 minute walking distance (6MWD)> 140 meters.

Exclusion criteria:

1. Active ischemic heart disease, significant arrhythmia. ejection fraction (EF) <40%.

2. COPD that cause carbon bioxide(CO2) retention above 50 mm Hg and / or oxygen saturation at rest below 88%.

3. Pulmonary hypertension> 45 mmHg, according to the Echo Test.

4. . 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 40-75 unlimited sex. 20 subjects

2. COPD, GOLD 3-4 (global obstructive lung disease).

3. CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.

4. Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.

5. 6 minute walking distance > 140 meters.

Exclusion Criteria:

1. Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.

2. Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.

3. Pulmonary hypertension> 45 mmHg, according to the Echo Test.

4. . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.

5. Pregnancy -

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Procedure:
• Endoscopic lung volume reduction
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Beer Yaakov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function improvemnt	Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .	6 months	Yes