Clinical trial · Observational
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Dysplastic Barrett's Esophagus | — | UNRESOLVED | — |
| Radiofrequency Ablation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation alone | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Changes in distensibility index (DI)
- timeFrame
- Every 12 weeks, up to 1 year (4 visits)
- description
- Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
- measure
- Changes in diameter
- timeFrame
- Every 12 weeks, up to 1 year (4 visits)
- description
- Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Secondary outcomes (1)
- measure
- Changes in mucosal impedance
- timeFrame
- Every 12 weeks, up to 1 year (4 visits)
- description
- Damage to the mucosal lining of the esophagus and measurement of esophageal leakiness will be assessed by sensors used during RFA procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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 EGD * Adults lacking the capacity to consent for self
References
Publications (0)
Data not yet available