Stretta Treatment in GERD After SG
NCT05094895 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2021-11-03
Summary
To evaluate the effect and explore the mechanism of action behind the potential effect of Stretta® on GERD after SG.
Conditions
- Stretta Device
Interventions
- PROCEDURE
-
Stretta
Radiofrequency energy delivered to the gastro-esophageal junction
- PROCEDURE
-
Sham
Patients that have the sham condition will have a procedure using a 24Fr Savary bougie dilator over the guidewire, with the same sedation.
Sponsors & Collaborators
-
Timshel BV
collaborator UNKNOWN -
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-29
- Primary Completion
- 2024-01-29
- Completion
- 2024-01-29
Countries
- Belgium
Study Locations
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