RECRUITING

Impact of RFA on Esophageal Distensibility and Mucosal Impedance

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients undergoing ablative therapy for management of dysplastic Barrett's Esophagus (BE) will have decreased distensibility over the course of treatment, but improvement in mucosal impedance as BE epithelia is replaced by neosquamous epithelia. This information may lead to further research in predicting therapeutic response and complications. The purpose of this research is to collect information while measuring changes related to the esophagus in patients that receive radiofrequency ablation (RFA) for dysplastic Barrett's Esophagus (BE) or esophageal cancer. Study participation includes measurements of the esophagus with the use of two different devices. This takes place during clinically indicated upper endoscopies during the timeframe the participant is receiving RFA treatments. This process will take up to an additional 10 minutes during the upper endoscopy and be done while the participant is sedated.

Official Title

Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation

Quick Facts

Study Start:2025-08-19
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07126535

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥ 18 years of age
  2. * Confirmed histologic diagnosis of BE with dysplasia or intramucosal carcinoma (IMCa)
  3. * Ability to take high-dose proton pump inhibitor (PPI) therapy (such as omeprazole 40 mg BID)
  4. * Willing to undergo multiple rounds of endoscopic eradication therapy (EET) for management of BE (which is the guideline clinical recommendation for management of this disease)
  1. * History of esophageal ablation
  2. * History of esophageal stricture
  3. * History of esophageal or gastric surgery
  4. * Pregnancy
  5. * History of achalasia
  6. * History of delayed gastric emptying confirmed by 4-hour gastric emptying study
  7. * Receipt of glucagon-like peptide-1 agonists
  8. * Adults lacking the capacity to consent for self
  9. * Lack of English fluency

Contacts and Locations

Study Contact

Mariah J Robran
CONTACT
(507)266-3595
robran.mariah@mayo.edu
Michele L Johnson
CONTACT
johnson.michele@mayo.edu

Principal Investigator

Chamil C Codipilly, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Chamil C Codipilly, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Registration Dates

Study Start Date2025-08-19
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-08-19
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Dysplastic Barrett's Esophagus
  • Radiofrequency Ablation
  • Barrett Esophagus