Cryo Balloon for Residual Barrett's Esophagus
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | August 2014 |
| End Date: | August 2019 |
CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro
ablation .
ablation .
Observational study of patients undergoing clinically indicated focal cryo ablation
Eligible patients for enrollment in this study must fulfill all of the following criteria:
1. Age > 18 years old
2. Able to provide informed consent
3. 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:
1. Age younger than 18 years old
2. Presence of esophageal varices
3. Esophageal stricture precluding passage of an endoscope
4. Inability to provide informed consent
5. Esophageal cancer (T2 and above)
6. Coagulopathy with INR > 2.0, thrombocytopenia with platelet counts < 50,000
7. pregnancy (if required a pregnancy test would be performed as part of routine clinical
care)
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