Dysplastic Barrett's EsophagusNCT07126535
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
An observational study of Dysplastic Barrett's Esophagus and Radiofrequency Ablation, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysplastic Barrett's Esophagus, Radiofrequency Ablation, Barrett Esophagus
- What is being tested?
- Radiofrequency ablation alone
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 31 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michele L Johnson contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Mariah J. Robran, 507-266-3595, robran.mariah@mayo.edu
Michele L. Johnson, 507-255-5504
About this study
Official title: Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
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.
- Being tested
- Radiofrequency ablation alone
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in distensibility index (DI)
Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Measured: 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.
Measured: Every 12 weeks, up to 1 year (4 visits)
Secondary outcomes (1)
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.
Measured: Every 12 weeks, up to 1 year (4 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start19 Aug 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysplastic Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chamil C Codipilly, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126535
- Sponsor's protocol ID
- 25-004350
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided