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

Stopped early · Not applicable

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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.

Key facts

Study ID

NCT01327963

Run by

EndoGastric Solutions

People needed

110

Starts

2010-09-01

Expected to finish

2014-02-01

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Munroe Regional Medical Center — Ocala, Florida, United States
• Livingston Hospital and Healthcare Services, Inc. CAH — Salem, Kentucky, United States

Full record on ClinicalTrials.gov

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