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OpenTrials
Completed

NCT Number: NCT02230410

Cryo Balloon for Residual Barrett's Esophagus

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.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CryoBalloon Focal Ablation

Device

Primary outcomes

  1. Eradication of Barrett's Esophagus

    Time frame: 3 months post Cryoballon Focal Ablation

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Pentax Medical

Registry information

Official study title

CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.

Acronym: Cryoballoon

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 3, 2014
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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