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Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair Combined With Transoral Incisionless Fundoplication Versus Laparoscopic Nissen Fundoplication for Treatment of Gastroesophageal Reflux Disease in Patients Requiring Hiatal Hernia Repair

NCT04795934•Mayo Clinic

View on ClinicalTrials.gov

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 hernia undergoing hernia repair.

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 22-80 years of age
•2. 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
•3. Pathologic reflux while off PPI based on Lyon criteria by either of the following:
•3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis.
•3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
•4. Commitment to long-term study
•5. Ability to give consent individually or by a legally authorized representative

Exclusion Criteria

•1. 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)
•2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
•3. Pregnancy (in females) at time of procedure
•4. Previous anti-reflux procedure
•5. Subjects requiring mesh treatment at time of procedure
•6. At the discretion of the site PI for subject safety
•7. BMI \> 35 at time of surgery.
•8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
•9. Severe gastroparesis

Locations (7)

University of California Irvine

Irvine, California, United States

University of Southern California

Los Angeles, California, United States

Institute of Esophageal and Reflux Surgery

Englewood, Colorado, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

The University of Texas at Austin

Austin, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Fox Valley Surgical

Appleton, Wisconsin, United States

Key Dates

Start Date

January 26, 2021

Primary Completion Date

July 31, 2025

Completion Date

January 1, 2030

Last Updated

August 19, 2025

Enrollment

142

ESTIMATED participants

Conditions

GERDHiatal Hernia

Interventions

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

PROCEDURE

Alginate vs Sucralfate for GERD Symptomatic Relief

NCT07310927

GERD

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RECRUITINGNA

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

NCT06953986

GERD

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RECRUITINGPHASE4

Famotidine and Antacids for Treatment of Dyspepsia

NCT06241183

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

Inclusion Criteria

Exclusion Criteria

Alginate vs Sucralfate for GERD Symptomatic Relief

A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA Grade B or Higher Reflux Esophagitis at 8 Weeks

Famotidine and Antacids for Treatment of Dyspepsia

Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients

Nissen Versus Dor Hiatal Hernia Repair

Stretta Versus Conservative Treatment