The TIF Registry Clinical Research Study

The TIF Registry research study will help further evaluate the efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device for treatment of GERD. We want to learn about how your GERD symptoms, esophageal acid exposure, medication usage and quality of life changes after the TIF surgery.

You are invited to participate in the study if you suffer from GERD and have a history of being treated with proton pump inhibitor medications (PPIs) but either continue to experience symptoms or prefer an alternative treatment.

Find the study center near you

TIF Registry Study Details

Approximately 500 subjects will take part in the TIF Registry study, which is conducted at several centers across the United States. The study will take a year to complete after the TIF procedure.

If you choose to participate, you will be asked to consent to the study and come for one or two screening office visits to determine your eligibility for this study. During the screening visits you will be interviewed by the study doctor and asked to complete questionnaires to assess your GERD symptoms and their impact on your quality of life. You may need to undergo pH testing to measure the acidity in your esophagus coming from the stomach and endoscopy procedure to measure the status of your esophagus and gastroesophageal junction. Then you will undergo the TIF procedure. You will return to the study doctor’s office for 3 routine follow-up visits 2 weeks, 1 month and 3 months after the procedure, and two assessment visits 6 months and 12 months after the procedure. At the 6 and 12 month follow-up visits you will be interviewed by the study doctor, asked to fill out the same questionnaires and undergo pH testing and endoscopy. Comparing your interviews, questionnaires and test results before and after the procedure will help evaluate the overall effectiveness of the procedure and its impact on your health and quality of life.

Find out if you are eligible to participate in the study.

Click on the link below to access the study registration site on www.clinicaltrials.gov.