Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.

Inclusion Criteria:

• Age 18-85 years
• Have undergone the TIF procedure within the past 2 years
• History of daily proton pump inhibitor (PPI) use for >6 months
• Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
• Deteriorated gastroesophageal junction (Hill grade II or III)
• Availability for a follow-up visit at 6,12 or 24 months
• Willingly and cognitively signed informed consent

Exclusion Criteria:

• Procedure not completed or performed following a non-standardized TIF protocol
• Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
• Pregnancy
• Enrollment in another device or drug study that may confound the results