Status:
ACTIVE_NOT_RECRUITING
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
EndoGastric Solutions
University of California, Irvine
Conditions:
GERD
Hiatal Hernia
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief Summary
This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal h...
Eligibility Criteria
Inclusion
- 22-80 years of age
- Subjects have GERD with hiatal hernia \< 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
- Pathologic reflux while off PPI based on Lyon criteria by either of the following:
- 1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis.
- 2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
- Commitment to long-term study
- Ability to give consent individually or by a legally authorized representative
Exclusion
- Hiatal hernia \> 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery)
- Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
- Pregnancy (in females) at time of procedure
- Previous anti-reflux procedure
- Subjects requiring mesh treatment at time of procedure
- At the discretion of the site PI for subject safety
- BMI \> 35 at time of surgery.
- Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
- Severe gastroparesis
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04795934
Start Date
January 26 2021
End Date
January 1 2030
Last Update
August 19 2025
Active Locations (7)
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1
University of California Irvine
Irvine, California, United States, 92697
2
University of Southern California
Los Angeles, California, United States, 90033
3
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, United States, 880113
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905