Pilot Study of the Spiration IBV™ System

Emphysema Clinical Trial

Official title: Pilot Study of the Spiration IBV™ System

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema

• NCT number: NCT00145548
• Study type: Interventional
• Source: Spiration, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: December 2003
• Completion date: August 2007