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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT07126535
- Acronym / sponsor ID
- 25-004350
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- History of esophageal ablation
- History of esophageal stricture
- History of esophageal or gastric surgery
- Pregnancy
- History of esophageal cancer treated with radiation or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation aloneIf 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. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Changes in mucosal impedance
Time frame: Every 12 weeks, up to 1 year (4 visits)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michele L Johnson contact
Chamil C Codipilly, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysplastic Barrett's Esophagus and Radiofrequency Ablation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariah J Robran ((507)266-3595, robran.mariah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in distensibility index (DI) (time frame: Every 12 weeks, up to 1 year (4 visits)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.