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

Inclusion Criteria4

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 Criteria9

History of esophageal ablation
History of esophageal stricture
History of esophageal or gastric surgery
Pregnancy
History of esophageal cancer treated with radiation or chemotherapy
History of achalasia
History of delayed gastric emptying confirmed by 4-hour gastric emptying study
Received injection of glucagon like peptide 1 agonists within a few days prior to EGD
Adults lacking the capacity to consent for self

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.