Recruiting

Radiofrequency Ablation

Sponsor:

Mayo Clinic

Code:

NCT07126535

Conditions

Dysplastic Barrett's Esophagus

Radiofrequency Ablation

Barrett Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiofrequency ablation alone

Study Details

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

Study ID

NCT07126535

Start date

Aug 19, 2025

Status verified date

Mar, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Changes in distensibility index (DI) [ Time Frame: Every 12 weeks, up to 1 year (4 visits) ]
  • Changes in diameter [ Time Frame: Every 12 weeks, up to 1 year (4 visits) ]

Central Contacts and Locations

Central contacts

Mariah J Robran

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

Michele L Johnson

johnson.michele@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Mariah J. Robran

507-266-3595robran.mariah@mayo.edu

Michele L. Johnson

507-255-5504

Principal Investigator:

Don Codipilly, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-30.