Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of Gastroesophageal Reflux Disease (GERD)
Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of Gastroesophageal Reflux Disease (GERD)
Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.
The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.
The study plan will include a screening/baseline visit, a surgical procedure phase with hospital stay until discharge, and study visits at 6 weeks, 3 months and 6 months after device implantation.
A follow-up will be performed annually from years 1-5 to evaluate long-term safety and performance with the intention to collect post-market long-term data using the GERD-HRQL score as a screening tool. Data of subjects who agreed to participate in the long-term safety and performance will be analysed after 1, 2, 3, 4 and 5 years.
At the screening/baseline visit, after signing the informed consent, the eligibility of subjects to receive treatment with the study device will be determined. Eligible subjects will then undergo the device implant procedure.
A standard laparoscopic approach will be used to reposition the lower esophageal sphincter (LES) to its intra-abdominal position. The RefluxStop™ device will then be positioned and fixed in the gastric fundus to ensure intra-abdominal positioning of the GEJ at all time. After confirming proper placement, the laparoscopic implant procedure will be completed and access points will be closed. The procedure will be recorded and saved only with study identification number and without subject ID information. The same applies for images on contrast swallow controlling the device.
Evaluations will be performed daily during hospitalisation and in an additional 3 study visits in the outpatient setting at 6 weeks, 3 months and 6 months. Subjects who have given their consent to participate in the long-term safety and performance follow-up part of the study will be followed annually from year 1-5.
A pathologically low pH in the lower esophagus is correlated to the development of precancerous changes/ Barrett's esophagus and fulminant cancer, as shown in the literature. Barrett's esophagus occurs in 1-2% of the total population while daily acid reflux patients have an incidence of 10-20% depending on the severity of the acid reflux [Modiano, Gerson 2007; Cossentino, Wong 2003]. As many as 48,000 people p.a. die in Europe and the US alone of esophageal adenocarcinoma, the primary cause of which is acid reflux. Therefore, in order to determine whether treatment is maintained in the longer-term, an additional 24-hour pH monitoring and simplified contrast swallow x-ray to verify the position of the device will be performed at 5 years for the benefit of the patients.
These long-term results have also been requested by the U.S. FDA. A quality control of the placement of the device will be categorized for subjects at after surgery, 6 months and 5 year follow-up and at therapy failure.
The position of the device is of utmost importance and will be categorized in the case of therapy failure.
To ensure a proper quality control, the contrast swallow x-ray determining eventual hiatal hernia performed before surgery is repeated at hospital stay after surgery and during the 6-month surgical outcome control and at 5-year follow-up. This x-ray is also used for categorizing the position of the device in a four-graded scale if therapy failure occurs and should be performed by the radiologist using the standard of care post-op contrast swallow.
Inclusion Criteria:
Exclusion Criteria:
Debrecen, 4031, Hungary
Székesfehérvár, H-8000, Hungary