Apreo BREATHE for Emphysema
(BREATHE-3 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGerard Criner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Apreo Health, Inc.

No Placebo Group

Trial Summary

What is the purpose of 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 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?

Eligibility Criteria

This trial is for adults with COPD and emphysema who still feel short of breath despite being on the best medical treatments. Up to 250 participants will be recruited from various centers in the US and Europe. People with certain health conditions that could interfere with the study or pose a risk may not qualify.

Inclusion Criteria

Subject has body mass index (BMI) of between 18 and 32, inclusive.

I can walk 100 meters or more in 6 minutes.

My CT scan shows at least 25% lung damage due to emphysema.

+15 more

Exclusion Criteria

I have severe lung damage that affects my COPD symptoms.

Subject has arterial or capillary blood on room air: PaCO2 > 50 mmHg or PaO2 ≤ 45 mmHg.

I have an ongoing lung infection that hasn't healed.

+18 more

Participant Groups

The trial is testing the Apreo BREATHE Airway Scaffold, a permanent implant designed to prop open airways and release trapped air, against Optimal Medical Management (OMM) alone. The goal is to see if it's safe and effective over three years.

2Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Apreo implants + Optimal Medical Management

Group II: Control GroupExperimental Treatment1 Intervention

Optimal Medical Management