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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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 ac
Sponsor: Assaf-Harofeh Medical Center

Current Primary Outcome: Pulmonary function improvemnt [ Time Frame: 6 months ]

Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assaf-Harofeh Medical Center

Dates:
Date Received: July 16, 2013
Date Started: February 2013
Date Completion: December 2014
Last Updated: August 8, 2013
Last Verified: August 2013