Bronchoscopic Vapour Therapy for Emphysema (unilateral treatment)

Not Applicable

Recruiting

• Conditions: Emphysema; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12609000822280
• Lead Sponsor: ptake Medical Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Heterogeneous emphysema with upper lobe predominance confirmed by computerized tomography (CT); ability to walk at least 140 meters; non-smoking for 3 months prior to study enrollment; completed pulmonary rehabilitation program

Exclusion Criteria

Known alpha 1 antitrypsin deficiency; previous heart or lung transplant; previous history of unstable myocardial ischemia; FEV1 < 15%, DLCO < 20%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: Pulmonary function via Forced Expiratory Volume in 1 second (FEV1) equal or greater than 12% as measured by plethysmography and spirometry[3 and 6 months following BTVA treatment];Primary Outcome 2: Quality of Life (QOL) via St Georges Respiratory Questionnaire (SGRQ) improvement equal or greater than 4 point score reduction[3 and 6 months following BTVA treatment]