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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01920321
Other study ID # 195/12
Secondary ID
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


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
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