Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

Description

The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?

Conditions

COPD, Emphysema

Study Overview

Study Details

Study overview

The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

Condition
COPD
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Temple University, Philadelphia, Pennsylvania, United States, 19140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    40 Years to 84 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Apreo Health, Inc.,

    Gerard Criner, MD, PRINCIPAL_INVESTIGATOR, Temple University

    Study Record Dates

    2029-12-31