Status:
COMPLETED
Cryotherapy -BEATS-RF Ablation Trial
Lead Sponsor:
Mayo Clinic
Conditions:
Barrett's Esophagus With Persistent Dysplasia or
Early Esophageal Adenocarcinoma Post Radio Frequency Ablation
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not ...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Able to provide informed consent
- Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
- Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
- Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment
Exclusion
- Age younger than 18 years old
- Life expectancy less than 12 months
- Pregnancy
- Presence of esophageal varices
- Esophageal stricture precluding passage of an endoscope and suction tubing
- Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
- Esophageal cancer (T2 and above)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01882478
Start Date
June 1 2013
End Date
June 1 2021
Last Update
October 20 2021
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905