NCT01041586

Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

US Pilot Safety and Feasibility Study of Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction in Patients With Heterogeneous Emphysema With Upper Lobe Predominance

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Uptake Medical Corp · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

Detailed description

All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments targeted for BTVA treatment. 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

• Emphysema
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	BTVA System	Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-01-01
• Completion: 2011-08-01
• First posted: 2009-12-31
• Last updated: 2012-02-23

Locations

4 sites across 1 country: United States