Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EndoGastric Solutions
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
