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

Not Applicable

Completed

Interventions: Other: Sham placebo procedure
Device: TIF Transoral Fundoplication

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sham placebo procedure	Sham placebo procedure	Sham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.
TIF Transoral Fundoplication	TIF Transoral Fundoplication	Intervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,	6 month follow up	Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.

Secondary Outcome Measures

Name	Time	Method
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score	6 months post procedure	DeMeester Score is a composite score taking into consideration reflux episodes, percentage of time pH is \< 4 and others. DMS was first reported in 1974 by Johnson and DeMeester. It is a composite score that measures acid exposure during prolonged ambulatory pH monitoring. The parameters that constitute the score are: 1. total number of episodes of reflux, - reflux is undesirable, therefore lower numbers are better, higher numbers are worse. Ideally there would be zero reflux episodes. 2. % total time esophageal pH \< 4, upright position and supine position, respectively - pH \< 4 is undesirable, therefor lower percentages are better 3. number of episodes longer than 5 minutes, - lower is better 4. maximal reflux duration, (reflux is undesirable - lower is better 5. total percentage of time with pH below 4 - below 4 is undesirable - lower is better The composite score can be obtained by adding the scores calculated for each of the six components.

Locations (9): Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Reston Surgical Associates
🇺🇸
Reston, Virginia, United States
Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
SurgOne PC
🇺🇸
Englewood, Colorado, United States
Ohio State University Hospital
🇺🇸
Columbus, Ohio, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
The Oregon Clinic
🇺🇸
Portland, Oregon, United States
University of Washington
🇺🇸
Seattle, Washington, United States
University of Texas, Health Science Center at Houston
🇺🇸
Houston, Texas, United States