Cryo Balloon for Residual Barrett's Esophagus
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT02230410
Sponsor Protocol Number: 14-004771
About this study
To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro ablation .
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Eligible patients for enrollment in this study must fulfill all of the following criteria:
- Age > 18 years old
- Able to provide informed consent
- Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection,
Exclusion from the study with any of the following:
- Age younger than 18 years old
- Presence of esophageal varices
- Esophageal stricture precluding passage of an endoscope
- Inability to provide informed consent
- Esophageal cancer (T2 and above)
- Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
- pregnancy (if required a pregnancy test would be performed as part of routine clinical care)
More information
Publications
Publications are currently not available