RecruitingNCT07126535

Impact of RFA on Esophageal Distensibility and Mucosal Impedance

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

Sponsor

Mayo Clinic

Enrollment

10 participants

Start Date

Aug 19, 2025

Study Type

OBSERVATIONAL

Conditions

Barrett Esophagus Radiofrequency Ablation Dysplastic Barrett's Esophagus

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at what happens to the esophagus (food pipe) after a heat-based treatment called radiofrequency ablation (RFA) — a procedure used to destroy abnormal cells in people with Barrett's esophagus, a condition where the lining of the food pipe changes in ways that could become cancerous. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Barrett's esophagus that has progressed to dysplasia (precancerous changes) or very early-stage cancer - You are able to take high-dose acid-reducing medication - You are willing to undergo multiple rounds of endoscopic treatment **You may NOT be eligible if...** - You have had prior esophageal ablation or esophageal surgery - You have an esophageal stricture (narrowing), achalasia (swallowing disorder), or slow stomach emptying - You are pregnant - You have had esophageal cancer treated with radiation or chemo - You recently received a GLP-1 injection (like Ozempic) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTRadiofrequency 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.