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

NCT01920321 | Unknown Phase 1 DMC

• 1 other identifier: 195/12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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;

Conditions

Emphysema

Keywords

COPD; Bronchoscopic LVR; Emphysema; Hot injury

Outcome Measures

Primary Outcomes (1)

• Pulmonary function improvemnt

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

  6 months

Study Arms (1)

Endoscopic lung volume reduction

EXPERIMENTAL

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

Interventions

Endoscopic lung volume reduction PROCEDURE

Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.

Endoscopic lung volume reduction

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-75 unlimited sex. 20 subjects
• COPD, GOLD 3-4 (global obstructive lung disease).
• CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
• Pulmonary function tests results- TLC\> 110%, RV\> 150%, DLCO \<80%,FEV1: 15-45%.
• minute walking distance \> 140 meters.

You may not qualify if:

• Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) \<40%.
• Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
• Pulmonary hypertension\> 45 mmHg, according to the Echo Test.
• Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
• Pregnancy -

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh Medical Center

Beer Yaakov, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• david Stav, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Stav, MD

CONTACT

972- 89779024; dstav@asaf.health.gov.il

Isaac Shpirer, MD

CONTACT

972- 89779024

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: August 12, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 12, 2013

Record last verified: 2013-08

Locations

IL (1)