Trials / Completed
CompletedNCT01102712
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Uptake Medical Corp · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.
Detailed description
All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BTVA System | Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2010-12-01
- Completion
- 2011-08-01
- First posted
- 2010-04-13
- Last updated
- 2012-02-23
Locations
10 sites across 4 countries: Australia, Austria, Germany, Ireland
Source: ClinicalTrials.gov record NCT01102712. Inclusion in this directory is not an endorsement.