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Impact of RFA on Esophageal Distensibility and Mucosal Impedance

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Mayo Clinic

Status

Enrolling

Conditions

Barrett Esophagus
Dysplastic Barrett's Esophagus
Radiofrequency Ablation

Treatments

Diagnostic Test: Radiofrequency ablation alone

Study type

Observational

Funder types

Other

Identifiers

NCT07126535
25-004350
NCI-2025-05191 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 achalasia
  • History of delayed gastric emptying confirmed by 4-hour gastric emptying study
  • Receipt of glucagon-like peptide-1 agonists
  • Adults lacking the capacity to consent for self
  • Lack of English fluency

Trial contacts and locations

1

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Central trial contact

Michele L Johnson; Mariah J Robran

Data sourced from clinicaltrials.gov

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