Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
With
EndoGastric Solutions
University of California, Irvine
Fox Valley Surgical Associates
University of Southern California
The University of Texas Health Science Center, Houston
University of Texas at Austin
Institute of Esophageal and Reflux Surgery
Age
22–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
