NCT00145548

Pilot Study of the Spiration IBV™ System

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a selected portion of the lung, producing a reduction in lung volume, which may improve pulmonary function in patients with emphysema.

Detailed description

This pilot study is an open enrollment, prospective study with each subject serving as their own control. The sponsor may attempt to include the data from this study in the statistical analysis of the pivotal study. This proposal shall be evaluated at the conclusion of the pilot study. PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment in this study. In this initial pilot study, eligible subjects will have severe, heterogeneous, predominantly upper lobe emphysema, as defined by the American Thoracic Society (ATS) 1 and the NETT Research Group.2 These subjects also will be patients who have been screened as potential candidates for LVRS, but who have been excluded from surgical treatment due to a failure to satisfy the inclusion and exclusion criteria established by the NETT Research Group for LVRS.2 Patients also will be able to tolerate a flexible bronchoscopy procedure. Patients who have been screened and accepted for a lung transplant procedure or LVRS, and are currently registered or scheduled for such a procedure, are not eligible for enrollment in this pilot study. Patients with an FEV1 \< 20% predicted and either homogeneous emphysema or DLCO \< 20% will be excluded from enrollment in this pilot study.3 Patients will be screened and enrolled until up to 115 subjects have undergone treatment with the IBV System. Up to 15 clinical centers will be selected to enroll and treat subjects.

Conditions

• Emphysema

Interventions

Type	Name	Description
DEVICE	Intra Bronchial Valve

Timeline

• Start date: 2003-12-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-09-05
• Last updated: 2011-06-16

Locations

14 sites across 1 country: United States