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Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

NCT01796392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2023-06-15

Study results available
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Summary

The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

Conditions

  • Emphysema

Interventions

DEVICE

EBV

This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

OTHER

Optimal Medical Management

This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Sponsors & Collaborators

  • Pulmonx Corporation

    lead INDUSTRY

Principal Investigators

  • Gerard Criner, MD · Temple University Hospital, Philadelphia, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-09-30
Completion
2023-04-30

Countries

  • United States
  • Brazil
  • 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 NCT01796392 on ClinicalTrials.gov