NCT07126535 · Mayo Clinic
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
What this study is 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
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 measures
Changes in distensibility index (DI)
Time frame: Every 12 weeks, up to 1 year (4 visits)
Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Changes in diameter
Time frame: Every 12 weeks, up to 1 year (4 visits)
Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Rochester, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations