Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Status: | Completed |
---|---|
Conditions: | Gastroesophageal Reflux Disease , Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/8/2019 |
Start Date: | April 2011 |
End Date: | March 2018 |
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
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.
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.
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.
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.
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.
We found this trial at
9
sites
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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