Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
NCT ID: NCT01920321
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2013-02-28
2014-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Endoscopic lung volume reduction
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.
Interventions
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Endoscopic lung volume reduction
Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.
Eligibility Criteria
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Inclusion Criteria
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
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 -
40 Years
75 Years
ALL
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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david Stav, MD
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Locations
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Assaf Harofeh Medical Center
Beer Yaakov, , Israel
Countries
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Central Contacts
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Isaac Shpirer, MD
Role: CONTACT
Phone: 972- 89779024
Other Identifiers
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195/12
Identifier Type: -
Identifier Source: org_study_id