RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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?

Official Title

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

Quick Facts

Study Start:2025-07-15
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06891755

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.

Ages Eligible for Study:40 Years to 84 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cindy Holtz
CONTACT
650-326-2656
cindy.holtz@apreohealth.com
Nina Mohmood
CONTACT
nina.mohmood@apreohealth.com

Principal Investigator

Gerard Criner, MD
PRINCIPAL_INVESTIGATOR
Temple University

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Banner Health
Gilbert, Arizona, 85234
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Orlando Health
Orlando, Florida, 32806
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, 15801
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States

Collaborators and Investigators

Sponsor: Apreo Health, Inc.

  • Gerard Criner, MD, PRINCIPAL_INVESTIGATOR, Temple University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Apreo
  • COPD
  • Emphysema
  • BREATHE System
  • Hyperinflation
  • Air-trapping
  • Apreo BREATHE Airway Scaffold
  • BREATHE Implant
  • Airway Scaffold
  • Apreo Health

Additional Relevant MeSH Terms

  • COPD
  • Emphysema