Barrett's Esophagus Clinical Trial
— CryoballoonOfficial title:
CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
| NCT number | NCT02230410 |
| Other study ID # | 14-004771 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2014 |
| Est. completion date | May 26, 2017 |
| Verified date | January 2022 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | May 26, 2017 |
| Est. primary completion date | May 26, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion 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 criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Rochester | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic | Pentax Medical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Eradication of Barrett's Esophagus | Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation | 3 months post Cryoballon Focal Ablation |
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