Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: EsophyX™ system with SerosaFuse fasteners


Participation Criteria
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Eligibility Criteria
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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: Erosive esophagitis (erosions or ulcerations during endoscopy) Abnormal ambulatory pH study 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 Esophageal stricture Esophageal motility disorder Prior splenectomy 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 Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment Coagulation disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EsophyX™ system with SerosaFuse fasteners|The EsophyX™ system with SerosaFuse fasteners (EndoGastric Solutions, Redmond, WA, USA) was designed to reconstruct the gastroesophageal junction through anterior partial fundoplication with tailored delivery of multiple fasteners during a single-device insertion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores |  | 1, 3, 6, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 day; 1 week; 1, 3, 6, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease (GERD), EsophyX