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

NCT01608490 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2021-07-19

Study results available
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Summary

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

Conditions

  • Emphysema

Interventions

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.

Sponsors & Collaborators

  • PneumRx, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Charlie Strange, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-12-31
Completion
2019-07-26

Countries

  • United States
  • Canada
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608490 on ClinicalTrials.gov