An observational study in Dysplastic Barrett's Esophagus, Radiofrequency Ablation and Barrett Esophagus, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Mayo Clinic · Observational
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.
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's planned enrollment of 10 is below the median of 127 across 115 observational studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from the Mayo Clinic Rochester Barrett's Esophagus practice. Clinic and upper endoscopy lists will be screened on a daily basis to identify patients who meet inclusion criteria. These patients will then be invited to participate in the study and screened by the study team.
Exclusion Criteria:
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.
Changes in distensibility index (DI)
Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Time frame: Every 12 weeks, up to 1 year (4 visits)
Changes in diameter
Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Time frame: Every 12 weeks, up to 1 year (4 visits)
Changes in mucosal impedance
Damage to the mucosal lining of the esophagus and measurement of esophageal leakiness will be assessed by sensors used during RFA procedure.
Time frame: Every 12 weeks, up to 1 year (4 visits)
GERD-Q Questionnaire
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) IS a 6-item questionnaire used to help diagnose GERD and assess the impact of symptoms on a patient's daily life. Scores range from 0-18 with higher scores indicating greater GERD symptoms.
Time frame: Every 12 weeks, up to 1 year (4 visits)
Reflux symptom index (RSI)
The RSI is used to measure impact of GERD symptoms over the past month. It consists of 9 symptoms which are rated on a scale of 0-5 where 0=no problem and 5=significant problem. Higher scores indicate greater impact of symptoms.
Time frame: Every 12 weeks, up to 1 year (4 visits)
Plan to share: Undecided
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