Status:

COMPLETED

Cryo Balloon for Residual Barrett's Esophagus

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

Pentax Medical

Conditions:

Barrett's Esophagus

Eligibility:

All Genders

18+ years

Phase:

NA

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 cryother...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    August 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 26 2017

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT02230410

    Start Date

    August 1 2014

    End Date

    May 26 2017

    Last Update

    February 10 2022

    Active Locations (1)

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    Mayo Clinic in Rochester

    Rochester, Minnesota, United States, 55905