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NCT03471052
Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch
NA trial testing Radiofrequency ablation (RFA) in Barrett Esophagus in 50 participants. Status unknown.
30 January 2021
Quick facts
| Lead sponsor | Guy's and St Thomas' NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 6 March 2018 |
| Primary completion | 30 January 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Radiofrequency ablation (RFA)
Conditions studied
- Barrett Esophagus — all drugs for Barrett Esophagus →
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Who can join
18 and older, any sex, with Barrett Esophagus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03471052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Radiofrequency ablation (RFA)
Trials testing the same drug.
- NCT05648565 — Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and · NA · completed
- NCT04348266 — RFA for GIM Treatment · NA · completed
- NCT04047173 — RFA Versus SBRT for Recurrent Small HCC · Phase 3 · completed
- NCT03621319 — Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique · NA · terminated
- NCT03898921 — RFA vs. SBRT for Small HCC · Phase 3 · unknown
Other recruiting trials for Barrett Esophagus
Currently open trials in the same condition.
- NCT07126535 — Impact of RFA on Esophageal Distensibility and Mucosal Impedance · recruiting
- NCT06746623 — Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux · NA · recruiting
- NCT06687603 — Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms · NA · recruiting
- NCT06803147 — "Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillan · recruiting
- NCT06693622 — Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests · recruiting
Other Guy's and St Thomas' NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07534917 — Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term. · not yet recruiting
- NCT07454135 — Mechanisms of Atrial Pathoelectrophysiology in HCM · not yet recruiting
- NCT07419945 — Older Kidney Patient Optimisation Pretransplant · NA · not yet recruiting
- NCT07309835 — Improving Genetic Medicine for Ethnic Minority Groups · not yet recruiting
- NCT07203872 — Inflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03471052 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Guy's and St Thomas' NHS Foundation Trust
- Last refreshed: 12 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03471052.
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