Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)

Study Overview
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Brief Summary
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The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

Detailed Description
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Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline. Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.

Official Title
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Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study

Conditions
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Gastroesophageal Reflux Disease, Hiatal Hernia

Intervention / Treatment
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* Procedure: TIF Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years GERD for > 1 year History of daily PPIs use for > 6 months Moderate to severe typical or atypical GERD symptoms off PPIs Complete (responders) or partial (nonresponders) symptom control on PPIs Deteriorated gastroesophageal junction (Hill grade II or III) Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing Willingness to undergo pH/impedance testing, if required Willingness to cooperate with the postoperative diet for 6 weeks Availability for follow up visits at 6 months and 12 months Willingly and cognitively signed informed consent Exclusion Criteria: BMI > 35 Incompletely reducible hiatal hernia with residual of > 5 mm Esophagitis grade D Barrett's Esophagus > 2 cm Esophageal ulcer Fixed esophageal stricture or narrowing Portal hypertension and/or varices 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 disorder History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis Pregnancy or plans of pregnancy in the next 12 months Enrollment in another device or drug study that may confound the results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TIF Procedure<br>Intervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. . | Procedure: TIF Procedure<br>* The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.<br>* Other names: TIF - Transoral Incisionless fundoplication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroesophageal Reflux Disease (GERD) symptom elimination | GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index). | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination of Proton Pump Inhibitor (PPI) usage | Elimination of Proton Pump Inhibitor (PPI) usage | at 12-, 24- and 36-month follow-up | 
| Esophageal acid exposure | Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4. | at 6-, 12-, 24- and 36-month follow-up | 
| Healing of reflux esophagitis | Healing of reflux esophagitis | at 12, 24- and 36-month follow-up | 
| Safety outcomes | Incidence of anticipated and unanticipated adverse events | first 30 days | 
| Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination | GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores. | at 12-, 24- and 36-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent