Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD
Objectives of the Study:
The primary objective of this study is to evaluate the relative merits, safety and
effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent
GERD symptoms despite PPI therapy.
The secondary objective of the study is to evaluate the effectiveness of the tailored TIF
procedure in restoring the antireflux barrier and eliminating GE reflux.
Type of Study:
Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20
Inclusion Criteria:
Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy,
anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of
the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during
endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic
of reflux esophagitis; acceptable esophageal motility (by either manometry or video
esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with
post-operative dietary recommendations and assessment tests, signed informed consent
Exclusion Criteria:
BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal
stricture, gastric motility disorders, previous splenectomy, pregnancy (female),
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, gastroparesis or delayed gastric emptying, coagulation disorders
Interventions:
Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with
SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)
Evaluation Criteria:
Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores;
GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs.
baseline off PPI's, total number of reflux episodes, and Symptom Association Probability
while off PPI.
Safety: Adverse events will be mapped to standard terms and reported.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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