MedTrace Logo

Impact of RFA on Esophageal Distensibility and Mucosal Impedance

NCT07126535 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Radiofrequency ablation alone

If there is no evidence of nodularity, these patients will undergo RFA. Clinical biopsies utilizing a large-capacity biopsy forceps (Radial Jaw 4, Boston Scientific, Marlborough, MA) are obtained. RFA may be delivered through several devices under the BarrX RFA System (Medtronic USA, Minnetonka, MN), including a circumferential balloon catheter (Halo 360; figure 1), or over the scope focal catheter (Halo 90 or 60). The Halo 360 treats a circumferential 4 cm segment at a time, whereas the focal catheters treat a 1.3x2 cm (Halo 90) or 1.0x1.5 cm (Halo 60) area.

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07126535 on ClinicalTrials.gov