BREATHE-2

• Research type

  Research Study

• Full title

  Bronchoscopic Release of Air Trapped in Hyperinflated Emphysematous Lung

• IRAS ID

  326148

• Contact name

  Pallav L. Shah

• Contact email

  Pallav.shah@ic.ac.uk

• Sponsor organisation

  Apreo Health, Inc.

• Clinicaltrials.gov Identifier

  NCT05949645

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Emphysema is a lung disease that results from damage to the walls of the alveoli of the lungs. A blockage (obstruction) may develop, which traps air inside the lungs. This multi-centre study is being carried out to assess the safety, feasibility and preliminary efficacy of the Apreo Implant for severe emphysema in up to 60 participants. The Apreo Implant is designed to open lung airways, allowing trapped air to escape, thereby reducing hyperinflation of the lungs.

  Initially all participants will undergo an Apreo Procedure involving placement of up to three implants in one lung followed by a second Apreo Procedure 30 days later to place up to three implants in the opposite lung if indicated.

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  23/SW/0074

• Date of REC Opinion

  19 Jun 2023

• REC opinion

  Favourable Opinion