Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study (RESPECT)
|Gastroesophageal Reflux Disease Hiatal Hernia||Device: Transoral Incisionless Fundoplication (TIF) Other: Sham Procedure|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- A clinically significant reduction in GERD symptoms (specifically "Troublesome" regurgitation with or without heartburn as assessed by the RDQ per the Montreal Consensus definition. [ Time Frame: 6 month follow up ]
Primary efficacy hypothesis 1: At 6-month follow-up, the proportion of TIF2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI treatment group.
Secondary efficacy hypothesis 1: At 6-month follow-up, with all patients off PPIs, the proportion of TIF patients with normalized esophageal acid exposure will be statistically significantly higher than the sham group.
- The normalization of esophageal acid exposure and healing of reflux esophagitis [ Time Frame: at 6 months and PPI usage at 12 months. ]At 12-month follow-up, ≥ 50% of the patients randomized to TIF will have a clinically significant reduction in PPI consumption as compared with their pre-TIF consumption. Clinical significant reduction is defined as from daily use to occasional use or none at all.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||March 2018|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sham placebo procedure
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.
Other: Sham Procedure
The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.
Active Comparator: TIF Transoral Fundoplication
TIF. Transoral Incisionless Fundoplication. the EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.
Device: Transoral Incisionless Fundoplication (TIF)
A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)
Other Name: TIF
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136980
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Colorado|
|Englewood, Colorado, United States, 80110|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Ohio|
|Ohio State University Hospital|
|Columbus, Ohio, United States, 43211|
|United States, Oregon|
|The Oregon Clinic|
|Portland, Oregon, United States, 97210|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|University of Texas, Health Science Center at Houston|
|Houston, Texas, United States, 77401|
|United States, Virginia|
|Reston Surgical Associates|
|Reston, Virginia, United States, 20190|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||John Hunter, MD FACS||Oregon Health and Science University|