Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study

A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls

The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.

Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).

Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.

Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.

Inclusion Criteria:

• Age 18-80 years
• Dependent upon daily PPIs for > 6 months
• Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent.

Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.

• Abnormal ambulatory pH study off PPI therapy for 7 days.
• Normal or near normal esophageal motility (by manometry)
• Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm
• Patient willing to cooperate with post-operative dietary recommendations and assessment tests
• Signed informed consent

Exclusion Criteria:

• BMI > 35
• Hiatal hernia > 2 cm
• Esophagitis Los Angeles grade C or D
• Esophageal ulcer
• Esophageal stricture
• Esophageal motility disorder
• Pregnancy or plans for pregnancy in the next 12 months (in females)
• Immunosuppression
• ASA > 2
• Portal hypertension and/or varices
• History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
• Active gastro-duodenal ulcer disease
• Gastric outlet obstruction or stenosis
• Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
• Coagulation disorders
• Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.