N/A
N=18
Cryo Balloon for Residual Barrett's Esophagus
Barrett's Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT02230410 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Eradication of Barrett's Esophagus — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CryoBalloon Focal Ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eradication of Barrett's Esophagus |
2 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02230410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.