GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery
NCT03143608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99
Last updated 2017-05-08
Summary
The investigators prospectively studied ninety nine GERD patients following laparoscopic hiatal surgery combined with transoral incisionless fundoplication at two community hospitals. General surgeons and gastroenterologists participated in the study. GERD questions were recorded before and at six and twelve months.
Conditions
- Gastro Esophageal Reflux
Interventions
- DEVICE
-
Esophyx
Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device
Sponsors & Collaborators
-
Peter G Mavrelis
lead INDIV
Principal Investigators
-
Peter Mavrelis, MD · The Methodist Hospital Research Institute
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-01
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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