Registry of Outcomes From AntiReflux Surgery
NCT02923362 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2500
Last updated 2023-02-21
Summary
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Conditions
- Gastroesophageal Reflux Disease
- Hiatal Hernia
Interventions
- PROCEDURE
-
Laparoscopic Fundoplication
The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.
- DEVICE
-
LINX Antireflux
The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.
Sponsors & Collaborators
-
The Heartburn Foundation
lead OTHER
Principal Investigators
-
Reginald Bell, MD · The Heartburn Foundation
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2023-03-31
- Completion
- 2025-05-31
Countries
- United States
Study Locations
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