Clinical Trials

Inclusion Criteria:

• 22 - 80 years of age.
• Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
• Pathologic reflux while off PPI based on Lyon criteria by either of the following:
  • Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
  • Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
• Commitment to long-term study.
• Ability to give consent individually or by a legally authorized representative.

Exclusion Criteria:

• Hiatal hernia > 5 cm.
• Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
• Pregnancy (in females) at time of procedure.
• Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
• Subjects requiring mesh treatment at time of procedure.
• Provider discretion.
• BMI > 35.