Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
NCT ID: NCT01136980
Last Updated: 2021-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2011-04-30
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Sham placebo 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.
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.
TIF Transoral Fundoplication
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)
Interventions
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TIF Transoral Fundoplication
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)
Sham placebo 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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EndoGastric Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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John Hunter, MD FACS
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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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
Countries
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References
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Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13.
Other Identifiers
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D01010
Identifier Type: -
Identifier Source: org_study_id