Status:
COMPLETED
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Lead Sponsor:
EndoGastric Solutions
Conditions:
Gastroesophageal Reflux Disease
Hiatal Hernia
Eligibility:
All Genders
18-80 years
Phase:
NA
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" ...
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 (RD...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01136980
Start Date
April 1 2011
End Date
March 1 2018
Last Update
December 3 2021
Active Locations (9)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
SurgOne PC
Englewood, Colorado, United States, 80110
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Ohio State University Hospital
Columbus, Ohio, United States, 43211