Clinical trial · Interventional
Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch
Randomised Controlled Trial of Radiofrequency Ablation Versus a Sham Procedure for Symptomatic Cervical Inlet Patch
- 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)
Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner (GP) referral to Ear Nose \& Throat departments. There is no recognised treatment. Drugs that reduce acid may help but do not block mucus production. Argon Plasma coagulation has been shown to be successful but limited to a few expert centres. The investigators have previously shown a device that uses radiofrequency energy to remove the patch to be highly effective in a ten patient pilot study, with 80% response rate that was durable over 1 year. The purpose of this trial is to demonstrate the previous study was not due to placebo effect alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months after sham. All males and non-pregnant females over 18 years old with previously diagnosed inlet patch causing symptoms of globus, with \> 50% severity on a visual analogue score, are eligible.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation (RFA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation (RFA)
- description
- Radiofrequency ablation (RFA)
- interventionNames
- Procedure: Radiofrequency ablation (RFA)
- type
- NO_INTERVENTION
- label
- Sham procedure
- description
- Endoscopy will be performed under conscious sedation and all BarrX RFA equipment will be set up in room. A sound recording of the BarrxTM RFA device will be played (a distinct bell sound that is emitted from the generator) during the procedure.
Primary outcomes (4)
- measure
- Reduction in globus symptoms
- timeFrame
- 6 months post ablation
- description
- \>50% reduction in globus as assessed by improvement in patient symptom scoring
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with symptoms secondary to Inlet patch and globus score \> 50 on Visual Analogue Scale (VAS) 2. Histological confirmation of presence of Inlet patch 3. Symptoms not responsive or partially responsive to (proton pump inhibitor) PPI therapy for \> = 6 weeks 4. Males and non-pregnant females over the age of 18 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception. 5. Patients must sign an informed consent form. Exclusion Criteria: 1. Patients in whom endoscopy is contraindicated. 2. No globus symptoms 3. Patients previously or currently treated for oesophageal dysplasia or cancer 4. Patients with eosinophilic oesophagitis 5. Patients with oesophageal varices 6. Previous radiotherapy 7. Patients who have undergone Hellers myotomy 8. Pregnant females. 9. People under the age of 18 years. 10. Evidence of major motility disorder on High resolution Manometry 11. Patients with pre-existing ENT disorders causing globus.
References
Publications (0)
Data not yet available