The PRO-SEAL study
Research type
Research Study
Full title
Platform Randomised feasibility trial Of Suction, Endobronchial valves and Autologous blood patch on air-Leak
IRAS ID
348034
Contact name
Steven Walker
Contact email
Sponsor organisation
North Bristol Trust
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
Secondary Spontaneous Pneumothorax (SSP) is where an abnormal collection of air develops in the space between the lung and the chest wall causing lung collapse. This can occur in people with pre-existing lung conditions.
To treat pneumothorax a chest drain is inserted between the ribs to drain the air. However, in 90% of cases, the lung heals slowly, due to their lung disease. If the air continues to leak for longer than 2 days, this is termed persistent air-leak (PAL). We don’t know the best way to manage this condition, and in practice we often wait for the leak to stop, a process that can take days to weeks. There are several other suggested ways of managing air leak, but this treatment pathway currently involves several steps and we don’t know which treatments should be given, in what order.
A new type of study, the "platform trial" is a clinical trial where multiple treatments can be studied at the same time and in different orders. These multi-arm and multi-stage studies are felt to be a more efficient way of conducting research. This study will look at various ways of helping PAL. These include using suction on end of drain, using a sample of patient’s own blood to help form a clot over the lung or use of a valve to stop the air leak.
REC name
London - Central Research Ethics Committee
REC reference
25/LO/0483
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion