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Cryo Balloon for Residual Barrett's Esophagus (Cryoballoon)

Primary Purpose

Barrett's Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CryoBalloon Focal Ablation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus focused on measuring Barrett's, high grade dysplasia, ablation, cyrotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

focal cryo ablation

Arm Description

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

Outcomes

Primary Outcome Measures

Eradication of Barrett's Esophagus
Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation

Secondary Outcome Measures

Full Information

First Posted
August 27, 2014
Last Updated
January 18, 2022
Sponsor
Mayo Clinic
Collaborators
Pentax Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02230410
Brief Title
Cryo Balloon for Residual Barrett's Esophagus
Acronym
Cryoballoon
Official Title
CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 26, 2017 (Actual)
Study Completion Date
May 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Pentax Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Barrett's, high grade dysplasia, ablation, cyrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
focal cryo ablation
Arm Type
Experimental
Arm Description
Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
Intervention Type
Device
Intervention Name(s)
CryoBalloon Focal Ablation
Primary Outcome Measure Information:
Title
Eradication of Barrett's Esophagus
Description
Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation
Time Frame
3 months post Cryoballon Focal Ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Wang, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Cryo Balloon for Residual Barrett's Esophagus

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