Cryo Balloon for Residual Barrett's Esophagus (Cryoballoon)

Mayo Clinic

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: CryoBalloon Focal Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02230410

14-004771

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

focal cryo ablation

Experimental group

Description:

Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment

Treatment:

Device: CryoBalloon Focal Ablation