NCT01608490

Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

Detailed description

This will be a prospective, multicenter, randomized, assessor-blinded, controlled study comparing outcomes between the LVRC and Control Groups. Subjects will be block randomized in an LVRC (Treatment) to Control ratio of 1:1. The randomization will be stratified by homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups.

Conditions

• Emphysema

Interventions

Type	Name	Description
DEVICE	RePneu Lung Volume Reduction Coil System	The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-12-01
• Completion: 2019-07-26
• First posted: 2012-05-31
• Last updated: 2021-07-19
• Results posted: 2017-06-27

Locations

29 sites across 6 countries: United States, Canada, France, Germany, Netherlands, United Kingdom