Status:
UNKNOWN
Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Inlet patch is a congenital anomaly of the upper oesophagus, consisting of stomach lining that is in an aberrant position. Prevalence is up to 10% on endoscopy studies and 5% on post mortem studies. T...
Eligibility Criteria
Inclusion
- Patients with symptoms secondary to Inlet patch and globus score \> 50 on Visual Analogue Scale (VAS)
- Histological confirmation of presence of Inlet patch
- Symptoms not responsive or partially responsive to (proton pump inhibitor) PPI therapy for \> = 6 weeks
- 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.
- Patients must sign an informed consent form.
Exclusion
- Patients in whom endoscopy is contraindicated.
- No globus symptoms
- Patients previously or currently treated for oesophageal dysplasia or cancer
- Patients with eosinophilic oesophagitis
- Patients with oesophageal varices
- Previous radiotherapy
- Patients who have undergone Hellers myotomy
- Pregnant females.
- People under the age of 18 years.
- Evidence of major motility disorder on High resolution Manometry
- Patients with pre-existing ENT disorders causing globus.
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03471052
Start Date
March 6 2018
End Date
September 30 2021
Last Update
February 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT