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Impact of RFA on Esophageal Distensibility and Mucosal Impedance

Recruitingn/aAges 18 Years - anyAllMayo Clinic
NCT07126535 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pa

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📋 Eligibility rules (as published)
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
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What it tests

  • Radiofrequency ablation alone
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Where

1 site
Mayo Clinic
Rochester, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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