The Effect of Ablation Therapy on Barrett's Esophagus (ablation IN BE)

March 9, 2026 updated by: Cadman Leggett, Mayo Clinic
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus

Description

Inclusion Criteria:

  • Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
  • Ability to provide informed consent

Exclusion Criteria:

  • Eastern Cooperative Oncology Group performance status 3 or 4
  • Inability to tolerate endoscopic procedures
  • Pregnancy: Females of child-bearing age will be screened with pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study
Other: Biopsy
Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment
Time Frame: at time of surveillance intervals
presence of persistent or recurrence of barrett's esophagus and/or dysplasia
at time of surveillance intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Cadman Leggett, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimated)

January 7, 2008

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 258-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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