Thinking of joining a study?

Register your interest

Become a volunteer?

NCT07126535 | RECRUITING | Dysplastic Barrett's Esophagus

Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Sponsor:

Mayo Clinic

Brief Summary:

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.

Condition or disease

Dysplastic Barrett's Esophagus

Radiofrequency Ablation

Barrett Esophagus

Intervention/treatment

Radiofrequency ablation alone

Study Type : OBSERVATIONAL
Estimated Enrollment : 10 participants
Official Title : Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
Actual Study Start Date : 2025-08-19
Estimated Primary Completion Date : 2027-07
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male or female ≥ 18 years of age
  • * Confirmed histologic diagnosis of BE with dysplasia or intramucosal carcinoma (IMCa)
  • * Ability to take high-dose proton pump inhibitor (PPI) therapy (such as omeprazole 40 mg BID)
  • * 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)
Exclusion Criteria
  • * History of esophageal ablation
  • * History of esophageal stricture
  • * History of esophageal or gastric surgery
  • * Pregnancy
  • * History of achalasia
  • * History of delayed gastric emptying confirmed by 4-hour gastric emptying study
  • * Receipt of glucagon-like peptide-1 agonists
  • * Adults lacking the capacity to consent for self
  • * Lack of English fluency
Impact of RFA on Esophageal Distensibility and Mucosal Impedance

Location Details

NCT07126535

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905