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Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

NCT01334307 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-07-21

No results posted yet for this study

Summary

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.

Conditions

  • Emphysema

Interventions

DEVICE

Lung Volume Reduction Coil (LVRC) (PneumRx)

Lung Volume Reduction Coil (LVRC)

DEVICE

Control

Standard of Care

Sponsors & Collaborators

  • PneumRx, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Pallav Shah, MD · Chelsea and Westminster Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-06-30
Completion
2013-09-30

Countries

  • 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 NCT01334307 on ClinicalTrials.gov