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Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

NCT03387982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2022-03-18

No results posted yet for this study

Summary

Barrett's esophagus is a condition in which the normal lining of the lower esophagus is replaced with cells that predispose an individual to development of esophageal cancer. Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is provided endoscopically, via a variety of approved techniques including endoscopic mucosal resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is pain, thus making pain an important factor when discussing treatment options. It is speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison trials exist to date. This multi-center, prospective cohort study aims to compare pre- and post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and clinicians with data from a well-designed prospective study may help guide future physician/patient treatment discussions.

Conditions

  • Barrett Esophagus

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Long Island Jewish Medical Center

    collaborator OTHER

  • Pentax Medical

    collaborator INDUSTRY

  • Virginia Commonwealth University

    collaborator OTHER

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Harshit Khara, MD · Geisinger Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-02-16
Completion
2021-02-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387982 on ClinicalTrials.gov