Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
- Conditions
- Hiatal HerniaGastroesophageal Reflux Disease
- Interventions
- Procedure: TIF Procedure
- Registration Number
- NCT01118585
- Lead Sponsor
- EndoGastric Solutions
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TIF Procedure TIF Procedure 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.. .
- Primary Outcome Measures
Name Time Method Gastroesophageal Reflux Disease (GERD) symptom elimination 6-month follow-up 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).
- Secondary Outcome Measures
Name Time Method Esophageal acid exposure at 6-, 12-, 24- and 36-month follow-up Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH \< 4.
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination at 12-, 24- and 36-month follow-up GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
Elimination of Proton Pump Inhibitor (PPI) usage at 12-, 24- and 36-month follow-up Elimination of Proton Pump Inhibitor (PPI) usage
Healing of reflux esophagitis at 12, 24- and 36-month follow-up Healing of reflux esophagitis
Safety outcomes first 30 days Incidence of anticipated and unanticipated adverse events
Trial Locations
- Locations (14)
The Surgeons Group of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Swedish Medical Center and SurgOne P.C.
🇺🇸Englewood, Colorado, United States
Master Center for Minimally Invasive Surgery
🇺🇸Southlake, Texas, United States
Munroe Regional Hospital
🇺🇸Ocala, Florida, United States
Crossville Medical Group
🇺🇸Crossville, Tennessee, United States
Livingston Hospital and Healthcare Services, Inc. CAH
🇺🇸Salem, Kentucky, United States
Tempe St. Luke's Hospital
🇺🇸Tempe, Arizona, United States
The University of Texas Health Science Center
🇺🇸Houston, Texas, United States
St Mary's Hospital
🇺🇸Hobart, Indiana, United States
Mt. Graham Regional Medical Center
🇺🇸Safford, Arizona, United States
Ihde Surgical Group, PA
🇺🇸Arlington, Texas, United States
Utah County Surgical Associates
🇺🇸Provo, Utah, United States
Reston Hospital
🇺🇸Reston, Virginia, United States
Allegan Surgical Associates
🇺🇸Allegan, Michigan, United States