BE-COLDPLAY
Research type
Research Study
Full title
Prospective feasibility study on the efficacy and safety of the Focal C2 CryoBalloonTM Ablation System in patients with Barrett’s Esophagus-related neoplasia
IRAS ID
255855
Contact name
Pushpsen Joshi
Contact email
Sponsor organisation
Joint research office
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Barrett’s Esophagus (BE) is a premalignant (pre-cancer) condition of the lower part of the oesophagus. Continuous backflow of stomach acid into the lower part of the esophagus can cause changes to the cells (dysplasia) and ultimately may result in the development of cancer. One way to treat BE is by cryoablation, which uses freezing cold to ablate (destroy) the unwanted tissue.
This study is evaluating the balloon-cryoablation as an ablation treatment for BE. The balloon is inserted through the endoscope (the tube that the doctor inserts to examine the oesophagus). The balloon is then inflated and cooled with a cryogen (nitrous oxide). The freezing cold surface of the balloon ablates (destroys) the BE cells upon contact with the esophagus, and then heals with normal esophageal tissue. Balloon-cryoablation has been studied in clinical trials that confirmed its safety in treating BE and provided early efficacy data.
The exact length of participation depends on the required number of treatments. Usually it takes multiple treatment sessions to remove all Barrett’s tissue. Each balloon-cryoablation treatment session will take about 30 minutes and treatments are performed approximately every 3 months. When endoscopy shows that there is no Barrett’s tissue left, tissue biopsies will be taken to confirm complete healing of the esophageal tissue under the microscope. If no Barrett’s tissue is left, there will be a follow-up endoscopy in 6 months and every year after that for five years. There will be a maximum of 5 treatment sessions with cry balloon ablation per patient. Escape treatments may be performed for lesions < 5mm with argon photocoagulation (heater probe), and lesions > 5 mm with endoscopic resection.
After every treatment session patients will receive a short daily questionnaire for 14 days and will receive a telephone call 7 days after treatment.
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/1360
Date of REC Opinion
18 Sep 2019
REC opinion
Favourable Opinion