- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136980
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study (RESPECT)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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Colorado
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Englewood, Colorado, United States, 80110
- SurgOne PC
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Ohio
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Columbus, Ohio, United States, 43211
- Ohio State University Hospital
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Portland, Oregon, United States, 97210
- The Oregon Clinic
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Texas
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Houston, Texas, United States, 77401
- University of Texas, Health Science Center at Houston
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Virginia
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Reston, Virginia, United States, 20190
- Reston Surgical Associates
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
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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 Names:
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Active Comparator: 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,
Time Frame: 6 month follow up
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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.
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6 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
Time Frame: 6 months post procedure
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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:
The composite score can be obtained by adding the scores calculated for each of the six components. |
6 months post procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Hunter, MD FACS, Oregon Health and Science University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D01010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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