CryoBalloon Focal Ablation for Barrett's Oesophagus
Research type
Research Study
Full title
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
IRAS ID
153305
Contact name
Rehan Haidry
Contact email
Sponsor organisation
C2 Therapeutics, Inc.
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Barrett’s Oesophagus is a pre-cancerous condition which is seen prior to the development of oesophageal cancer. In Barrett's oesophagus the normal lining of the gullet (oesophagus) is replaced by cells that would normally line the stomach or bowel (a process called metaplasia). It is thought that this develops as a result of longstanding exposure to refluxed stomach acid, enzymes and bile, causing injury and inflammation. It is easily detectable at routine endoscopy. Because the survival from fully developed oesophageal cancer is so bad it is very attractive to try and tackle the disease at at an early stage when there are pre-cancerous cells (high grade dysplasia). High-grade dysplasia (HGD) is the stage which immediately precedes the occurrence of cancer. We do know that up to 60% of patients with HGD will develop cancer within 5 years.
Newer techniques that can remove these abnormal pre-cancerous cells at the time of endoscopy with thermal energy (ablation) are now recommended as first line treatment for dysplasia within Barrett's Oesophagus (BE). At present the most widely used technique is radiofrequency ablation.
The CryoBalloon Focal Abation system has been developed in the hope of improving the present techniques by producing shorter and safer procedures for patients whilst ensuring efficacy remains the same. The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation Device for the treatment of small islands of BE in patient's undergoing treatment for BE related neoplasia at UCLH. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 6 to 8 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken to assess efficacy of treatment.
REC name
London - Stanmore Research Ethics Committee
REC reference
14/LO/1852
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion