Impact of RFA on Esophageal Distensibility and Mucosal Impedance

NCT07126535 | Recruiting

• 1 other identifier: 25-004350
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysplastic Barrett's Esophagus; Radiofrequency Ablation; Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

• Changes in distensibility index (DI)

  Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.

  Every 12 weeks, up to 1 year (4 visits)

• Changes in diameter

  Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.

  Every 12 weeks, up to 1 year (4 visits)

Secondary Outcomes (1)

• Changes in mucosal impedance

  Every 12 weeks, up to 1 year (4 visits)

Other Outcomes (2)

• GERD-Q Questionnaire

  Every 12 weeks, up to 1 year (4 visits)

• Reflux symptom index (RSI)

  Every 12 weeks, up to 1 year (4 visits)

Interventions

Radiofrequency ablation alone DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the Mayo Clinic Rochester Barrett's Esophagus practice. Clinic and upper endoscopy lists will be screened on a daily basis to identify patients who meet inclusion criteria. These patients will then be invited to participate in the study and screened by the study team.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Esophageal biopsies

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Chamil C Codipilly, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariah J Robran

CONTACT

(507)266-3595; robran.mariah@mayo.edu

Michele L Johnson

CONTACT

johnson.michele@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)