Bronchoscopic Vapour Therapy for Emphysema

Completed

• Conditions: Emphysema; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12607000602426
• Lead Sponsor: ptake Medical Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients diagnosed with heterogeneous emphysema with upper lobe predominance as evidence by Computed Tomography (CT) imaging

FEV1 > 45% predicted; Total Lung Capacity (TLC) / 100% predicted; Residual Volume (RV) > 150% predicted

Exercise Capacity: Ability to walk > 140 metres in 6 minutes after completing a pulmonary rehabilitation program

Non-smoking for 4 months prior to study enrollment

Dyspnea scoring > or = 2 (of 4)

Exclusion Criteria

Patients diagnosed with homogeneous emphysema or heterogeneous emphysema with lower lobe predominance

Known alpha-1 antityrpsin deficiency

Body Mass Index (BMI) < 15kg/m2 or > 35 kg/m2 - body mass index is the relationship between weight and height that is associated with body fat and health risk

Clinically significant asthma, chronic bronchitis or bronchiectasis

Patients with heart/lung transplant or prior lung volume reduction surgery

Patients with significant pulmonary hypertension, heart disease or history of stroke

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All serious and non-serious events secondary to the BTVA procedure[Initiation through 6 months after intervention]

Secondary Outcome Measures

Name	Time	Method
Pulmonary Function Status as measured by Forced Expiratory Volume in 1 second (FEV1) and Diffusing Capacity of Lung - carbon monoxide (DLCO).[3 and 6 months after intervention];Exercise capacity (6 minute walk test)[3 and 6 months after intervention];Quality of Life (St. George Respiratory Questionnaire)[3 and 6 months after intervention]