Frequently Asked Questions
Q: How is TIF performed?
A: It is performed with the patient under general anesthesia. The EsophyX device is slowly introduced into the body transorally (through the mouth) and advanced into the esophagus under visualization of a video camera inserted down the central shaft of the device. The EsophyX device is then used to form and fasten several tissue folds, or plications, to create a robust antireflux valve at the gastroesophageal junction.
View animation of the TIF procedure using EsophyX
Q: How long does the procedure take?
A: The procedure takes approximately 60 minutes.
Q: How long can I expect to be hospitalized?
A: The procedure is performed in the hospital setting. You will be required to spend the night after the procedure in the hospital.
Q: What is the recovery like?
A: Patients should expect to experience some discomfort in their throat and chest for the first few days to a week after the procedure. Patients will be asked to restrict physical activity for the first week and will be given dietary guidelines to help maximize their success while the tissue heals.
Q: How soon can I return to work?
A: Most patients will be able to return to work within 3-7 days after the procedure, or as recommended by their study doctor.
Q: Are there risks or side effects associated with the procedure?
A: The procedure has been generally proven safe in hundreds of surgeries performed worldwide. To date, most observed side effects or discomforts have been mild. Previous research studies have shown that the nature and the number of adverse events associated with the procedure are similar to other procedures that involve acid reflux surgery. Discuss with your study doctor all potential risks and side effects and whether you are the right candidate for the procedure.
Q: What results should I expect?
Two U.S. case series with 161 patients reported a significant improvement in symptoms and PPI discontinuation in 80-90% patients, and normal esophageal acid exposure in 70%.
Q: What do I need to do to determine whether or not I am eligible for the TIF Registry study?
A: A Study Doctor at your nearest study location will determine your eligibility. Click on the link below to find the nearest study site and contact the Study Doctor.
Find and contact a study center near you
Q: What will I have to do if I decide to participate in the study?
A: After you agree to participate in the study and sign the informed consent form, you will undergo the following screening procedures to determine if you are eligible for the study.
- Interview by the study doctor
- Complete a medical history
- Give urine for a pregnancy test, if you are female
- Undergo an endoscopy to determine the current status of your esophagus and the junction between your esophagus and the stomach, if required
- Undergo a pH testing to measure the level of acidity in your esophagus, if required
- Answer three short questionnaires twice (while on-PPI and off-PPI medications) on the frequency and severity of your GERD symptoms, and how they impact your quality of life
Q: Is TIF using EsophyX FDA cleared?
A: The EsophyX device was cleared by the United States Food and Drug Administration (FDA) in 2007 for treatment of symptomatic chronic GERD after it had been proven safe and effective.
Q: Can I have the TIF procedure and not be a part of the study?
A: Yes, the treatment options available to you will not depend on your decision to participate or not participate in this study. If TIF was offered to you as a treatment option, you may still proceed with this treatment regardless of your participation in this study.
Q: What are my options if I am not eligible for the study?
A: If you are not eligible for the study, discuss alternative treatment options with the Study Doctor.
Q: What are the benefits of participating in the study?
A: Your GERD symptoms may improve or even go away as a result of your participation in this study. The information from this research study may lead to a better treatment in the future for people with GERD.
Q: What will my diet be after the TIF procedure?
A: After the procedure you will be on a diet of liquid foods for 2 weeks, soft foods for another 2 weeks, and then on a normal diet without fibrous vegetables and meet for 2 more weeks. You will advance to general diet after week 6.
Q: What is the expected follow-up after surgery?
A: Your follow-up will consist of routine office visits at week 2, month 1 and month 3 after the surgery, and two assessment visits at month 6 and month 12.
Q: Who will pay for the surgery?
A: The costs of TIF procedure and all study-related tests will be billed to your insurance company. You should ask your study doctor what costs will or will not be covered by your insurance.
Q: Will I be paid if I take part in this research study?
A: You will receive a payment of $100 for completing each 6-month and 12-month follow-up visit to a total of $200.
Q: Can I voluntarily withdraw from the study?
A: Taking part in this study is voluntary. You can withdraw your consent or discontinue participation in this study at any time. Your decision to leave the study will not cause any penalty or loss of benefits to which you are entitled.
Q: What company is responsible for the TIF Registry Clinical Research Study?
A: The company responsible for this study is EndoGastric Solutions, Inc. headquartered in Redmond, WA. EndoGastric Solutions, Inc. is a medical device company developing technologies for Natural Orifice Surgery (NOS), which is the next step in the evolution of minimally invasive surgery.