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

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ClinicalTrials.gov Identifier: NCT01920321
Recruitment Status : Unknown
Verified August 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date  ICMJE July 16, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Pulmonary function improvemnt [ Time Frame: 6 months ]
Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Emphysema
Intervention  ICMJE Procedure: Endoscopic lung volume reduction
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.
Study Arms  ICMJE 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.
Intervention: Procedure: Endoscopic lung volume reduction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920321
Other Study ID Numbers  ICMJE 195/12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assaf-Harofeh Medical Center
Study Sponsor  ICMJE Assaf-Harofeh Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: david Stav, MD Assaf-Harofeh Medical Center
PRS Account Assaf-Harofeh Medical Center
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP