Trial record 11 of 90 for:    Open Studies | "Emphysema"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01920321
First received: July 16, 2013
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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;


Condition Intervention Phase
Emphysema
Procedure: Endoscopic lung volume reduction
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Pulmonary function improvemnt [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic lung volume reduction
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.
Procedure: Endoscopic lung volume reduction
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920321

Contacts
Contact: David Stav, MD 972- 89779024 dstav@asaf.health.gov.il
Contact: Isaac Shpirer, MD 972- 89779024

Locations
Israel
Assaf Harofeh Medical Center Recruiting
Beer Yaakov, Israel, 70300
Principal Investigator: David Stav, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: david Stav, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01920321     History of Changes
Other Study ID Numbers: 195/12
Study First Received: July 16, 2013
Last Updated: August 8, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
COPD
Bronchoscopic LVR
Emphysema
Hot injury

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014