Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Completed · Not applicable · Has a placebo group
Conditions studied: Gastroesophageal Reflux Disease, Hiatal Hernia
In brief
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.
Key facts
- Study ID
- NCT01136980
- Run by
- EndoGastric Solutions
- People needed
- 129
- Starts
- 2011-04-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2021-12-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- SurgOne PC — Englewood, Colorado, United States
- Northwestern University — Chicago, Illinois, United States
- Ohio State University Hospital — Columbus, Ohio, United States
- The Oregon Clinic — Portland, Oregon, United States
- Oregon Health and Science University — Portland, Oregon, United States
- University of Texas, Health Science Center at Houston — Houston, Texas, United States
- Reston Surgical Associates — Reston, Virginia, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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