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

• Elimination of Proton Pump Inhibitor (PPI) usage [ Time Frame: at 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
• Esophageal acid exposure [ Time Frame: at 6-, 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
  Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.
• Healing of reflux esophagitis [ Time Frame: at 12, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
• Safety outcomes [ Time Frame: first 30 days ] [ Designated as safety issue: Yes ]
  Incidence of anticipated and unanticipated adverse events
• Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: at 12-, 24- and 36-month follow-up ] [ Designated as safety issue: No ]
  GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.

• Elimination of PPI usage [ Time Frame: at 6 and 12 month follow-up ] [ Designated as safety issue: No ]
• Esophageal acid exposure [ Time Frame: at 6 and 12 month follow-up ] [ Designated as safety issue: No ]
  Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.
• Healing of reflux esophagitis [ Time Frame: at 6 and 12 month follow-up ] [ Designated as safety issue: No ]
• Safety outcomes [ Time Frame: first 30 days ] [ Designated as safety issue: Yes ]
  Incidence of anticipated and unanticipated adverse events
• GERD symptoms [ Time Frame: at 12 month follow-up ] [ Designated as safety issue: No ]
  GERD symptom elimination or clinically significant reduction is defined as ≥ 50% improvement in the total QOLRAD, GSRS and RSI scores compared to baseline off PPIs.

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.

• Gastroesophageal Reflux Disease
• Hiatal Hernia

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