The registry population will consist of adult subjects diagnosed with GERD who are deemed suitable for the procedure by the investigator given the information provided in the instructions for use. For more information about the clinical study or to determine if you are eligible for the trial, patients can directly contact participating medical centers. Roy-Shapira A, Bapaye A, Date S, Pujari R, Dorwat S. Trans-oral anterior fundoplication: 5-year follow-up of pilot study. After the procedures, all three patients were released from the hospital in 2 days with no complications and have since reported improvement in reflux symptoms, reduced or eliminated anti-reflux drug use and no pain or discomfort after treatment. I am honored to be one of the first and most experienced gastroenterologists using MUSE to help patients with GERD. Patients consume a transition diet for five to seven days and then resume eating normally. Surgical Endoscopy. Device or procedure-related adverse events and serious adverse events will be evaluated for onset, frequency and duration. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. This is great news for GERD sufferers who are looking for a minimally invasive procedure with long-term positive outcomes. 2015 Jan;29(1):220-9. doi: 10.1007/s00464-014-3731-3. Two of her children have dealt with acid reflux disease, food allergies, migraines, and asthma. Patients will be admitted to the hospital post procedure for overnight observation. Talk with your doctor and family members or friends about deciding to join a study. Study details were published in Surgical Endoscopy in 2015. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: Six-month results from a multi-center prospective trial. In follow-up visits, all three patients have reported feeling significant relief from their GERD symptoms.”. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Nothing in this press release should be deemed to be medical or other advice of any kind. MUSE appears to be a resendable first step intervention in patients that are requiring or requesting anti-reflux procedure, considering its safety profile and minimally invasive nature. “We are proud to partner with a leading name in the field of gastroenterology, such as Professor Testoni, to offer a less-invasive and more cost-effective option to patients, physicians and the health care system in Italy, where GERD is prevalent,” Chris Rowland, CEO of Medigus, said in the release. © 1998-2020 Mayo Foundation for Medical Education and Research. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study. Epub 2015 Mar 18. By their nature, Forward-Looking Statements involve known and unknown risks, uncertainties and other factors which may cause future results of the company's activity to differ significantly from the content and implications of such statements. The goal of therapy is to control both the symptoms and mucosal damage. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Choosing to participate in a study is an important personal decision. All rights reserved. Why Should I Register and Submit Results?