Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema — BREATHE-2  

Emphysema or COPD Clinical Trial

Official title: Bronchoscopic Release of Air Trapped in Hyperinflated Emphysematous Lung

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).

Clinical Trial Description

This is a first-in-human, prospective, multi-center, single-arm study assessing the safety, feasibility and preliminary efficacy of the Apreo Implant for severe emphysema in up to 30 participants. Initially all participants will undergo an Apreo Procedure involving placement of up to three implants in a native bronchial tree of one lung followed by a second Apreo Procedure 30 days later to place up to three implants in the contralateral native lung bronchial tree if indicated. Once the fifth participant has undergone his or her first implantation procedure, implantations in currently enrolled or new participants will be paused to allow for a Safety Review Committee (SRC) to convene and review safety data once the 5th participant has completed the 7-day phone follow-up after their second Apreo Procedure (or first if only one procedure). This would be at a minimum acute procedural safety for up to 10 implantation procedures conducted in these first 5 participants, 30-day safety assessments for all 5 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. The SRC will provide comments and recommendations, including the restart of implantation for new participants, if deemed appropriate. After the first 10 participants have completed the 7-day phone follow-up after the second Apreo Procedure (or first if only one procedure), their safety data will be reviewed by the SRC. This would include at a minimum acute procedural safety for up to 20 implantation procedures conducted in these first 10 participants, 30-day safety assessments for all 10 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. Following the review of the first 10 participants' safety data, the SRC may allow any subsequently enrolled participants to undergo one Apreo Procedure (rather than two separate procedures if appropriate for a participant) to deploy Apreo Implants in both the left and right lung airways as indicated or to continue to have all participants undergo two separate Apreo Procedures if indicated. A total of up to 30 participants will be enrolled overall. All participants will be followed at 30 days, three, six and twelve months post the first Apreo Procedure and assessments include adverse event (AE) assessment, pulmonary function testing, bronchoscopy, and quality of life assessments (Day 30, and 3, 6, and 12 months) and an inspiratory/expiratory chest CT at 6 and 12 months. A phone follow-up for AE assessment will occur at 7 days after each Apreo Procedure. ;

Related Conditions & MeSH terms

• Emphysema
• Emphysema or COPD
• Pulmonary Emphysema

• NCT number: NCT05949645
• Study type: Interventional
• Source: Apreo Health, Inc.
• Contact: Shirin R Hasan
• Phone: +1-408-250-5881
• Email: shasan@thefoundry.com
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Completion date: July 2025