C2 CryoBalloon Ablation International Research Database Registry
Research type
Research Database
IRAS ID
280855
Contact name
Vinay Sehgal
Contact email
Research summary
A Multicentre International Research Database Registry Evaluating the Focal C2 CryoBalloon Ablation System for Barrett’s Oesophagus-related Neoplasia
REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0143
Date of REC Opinion
4 Aug 2021
REC opinion
Further Information Favourable Opinion
Data collection arrangements
Research team will obtain this written consent from patients who agree to participate. Original written consent form will be kept in the study site file, a copy filed in participants' hospital medical records and a copy will be given to the enrolled patient. Non-identifiable participant data which include medical history and treatments will be collected from patients’ hospital records and will be recorded on study paper Case Report Forms (CRFs). The CRFs will identify participants with unique allocated participant numbers and identifiable personal information will not be used. The research team will maintain a file with key records for enrolled patients and will be the only people who will be able to deduce the identity enrolled patients. Non-identifiable data recorded on paper CRFs is then uploaded on the C2 CryoBalloon Ablation registry database. Participant medical information will be stored electronically within the C2 CryoBalloon Ablation International Registry database. Access to the patient’s medical records and registry database will be through individual login access (username and password), allowing generation of audit trails. UCLH will keep identifiable information about patients for 20 years and data that will be collected on the electronic registry database will be kept for 7 years after end of study.
Research programme
C2 CryoBalloon Ablation International Registry aims to enable auditing of a new treatment for Barrett’s (BE)-related neoplasia (a pre-cancerous change to the lining of the swallowing tube) called Cryoablation. Studies have suggested that this treatment is safe and effective. The United Kingdom based National Institute for Healthcare and Clinical Excellence has looked at the results of these studies and has concluded that there is need for more information to be certain about the benefits of this treatment in BE-related neoplasia. They have therefore advised that further information is collected in patients treated with Cryoablation using a registry. Barrett’s oesophagus is a complication of gastroesophageal reflux disease that occurs when stomach acid and enzymes damage the oesophagus (food pipe). Over time, the cells lining the oesophagus are replaced with abnormal cells, putting patients at risk of developing cancer of the oesophagus. The purpose of this registry is to evaluate the safety and efficacy of balloon-cryoablation therapy. This is multi-centre registry aimed at collecting the important safety and efficacy data that is needed to further ascertain the benefits of Cryotherapy in patients with BE-related neoplasia.
Research database title
A Multicentre International Research Database Registry Evaluating the Focal C2 CryoBalloon Ablation System for Barrett’s Oesophagus-related Neoplasia
Establishment organisation
University College London Hospitals NHS Foundation Trust
Establishment organisation address
235 Euston Road
Fitzrovia
London
NW1 2BU