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

Status:	Terminated
Conditions:	Gastroesophageal Reflux Disease , Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 85
Updated:	3/8/2019
Start Date:	September 2010
End Date:	February 2014

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

The purpose of this open-label, postmarket study is to evaluate the safety and efficacy of
transoral incisionless fundoplication (TIF) performed with EsophyX in a broad range of
gastroesophageal reflux disease (GERD) patients treated at high volume centers across the
United States.

This open-label, postmarket study evaluates the safety and efficacy of transoral incisionless
fundoplication (TIF) performed with EsophyX 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

- Availability for a follow-up visit at 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 GI conditions such as dyspepsia, celiac disease, IBS or
Crohn's disease

- Pregnancy

- Enrollment in another device or drug study that may confound the results

We found this trial at

sites

Reston Surgical Associates

Reston, Virginia 20190

from

Reston, VA