Apreo BREATHE System for COPD and Emphysema

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

Recruiting N/A Interventional Study
COPD Emphysema
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 84
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Apreo Health, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with COPD and emphysema who experience difficulty breathing. Participants will receive a device to help open their airways and will be followed for three years.

Are You a Good Fit for This Trial?
Rules you out Pulmonary arterial hypertensionSignificant immunocompromised state

You may be able to join if

  • I am between 40 and 84 years old.
  • I have a BMI between 18 and 32.
  • I completed a pulmonary rehabilitation program in the last year.
  • I can walk at least 100 meters in 6 minutes.
  • I have at least 25% emphysema destruction in each lung.
  • I have been receiving optimal medical treatment for my condition.
  • I have not smoked in the last 4 months and agree to quit during the study.
  • I have provided written consent to participate.

You may not be able to join if

  • I have a serious lung infection like pneumonia or tuberculosis.
  • I need daily steroid medication.
  • I have had two or more hospitalizations for COPD in the last year.
  • I have had previous lung surgery or device implantation.
  • I have unresolved lung cancer.
  • I am pregnant or plan to become pregnant during the study.
  • I have a serious medical condition that could affect my safety.
  • I have allergies to medications needed for the procedure.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 includ…
Trial Locations
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Eligibility Criteria
* Inclusion Criteria 1. Subject is at least 40, but not older than 84, years of age. 2. Subject has body mass index (BMI) of between 18 and 32, inclusive. 3. Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline. 4. Subject has mMRC score ≥ 2…
Contacts

Cindy Holtz

650-326-2656

cindy.holtz@apreohealth.com

CONTACT

Nina Mohmood

nina.mohmood@apreohealth.com

CONTACT