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

Inclusion Criteria:

1. 22-80 years of age

2. Subjects have GERD with hiatal hernia < 5 cm (defined as maximum ,axial height fromend of the esophagus to diaphragm by any study including upper endoscopy esophagramand 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 thefollowing 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 todiaphragm by any study including upper endoscopy esophagram and or at time ofsurgery)

2. Evidence of clinically significant major esophageal motility disorder as determinedby 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 affectnormal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy,pyloroplasty.

9. Severe gastroparesis