Actively Recruiting
Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
Led by Mayo Clinic · Updated on 2026-03-30
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with dysplastic Barrett's Esophagus (BE) who are receiving radiofrequency ablation (RFA) treatment. The goal is to observe how the esophagus changes during treatment, specifically looking at decreased distensibility and improved mucosal impedance as abnormal tissue is replaced by new tissue. This research aims to better understand treatment response and potential complications in these patients. Participants will receive RFA treatments using devices from the BarrX RFA System, including the Halo 360 circumferential balloon catheter or focal catheters (Halo 90 or Halo 60). Treatments target specific areas of the esophagus depending on disease presence. Measurements of the esophagus will be taken with two devices during routine upper endoscopies while the participant is sedated. These extra measurements add about 10 minutes to the endoscopy. During the study, participants will be monitored up to four times every 12 weeks over one year. Researchers will measure changes in the esophageal distensibility index, diameter, and mucosal impedance to assess treatment effects. These evaluations occur during clinically indicated endoscopies as part of the participant's care. The study is observational and led by the Mayo Clinic.
CONDITIONS
Brief Title
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Confirmed histologic diagnosis of Barrett's Esophagus with dysplasia or intramucosal carcinoma
- Ability to take high-dose proton pump inhibitor therapy such as omeprazole 40 mg twice daily
- Willingness to undergo multiple rounds of endoscopic eradication therapy for Barrett's Esophagus
You will not qualify if you...
- 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 endoscopy
- Adults lacking the capacity to consent for themselves
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo radiofrequency ablation (RFA) and clinical biopsies to assess esophageal tissue.
4 visits every 12 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
M
Mariah J Robran
M
Michele L Johnson
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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