A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD.
Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.
Willing and able to provide informed consent and to participate in the registry study;
Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
24-hour pH or impedance pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be < 4 for ≥ 4.5% of total time during a 24-hour monitoring) and/or total reflux episodes >55 or weekly acid >26 for > 5 seconds, all measured 5 cm above LES);
Hiatal Hernia larger than 8 cm;
Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
History of bariatric surgery wherein the stomach fundus has been extirpated;
Female subjects who are pregnant;
Single group
RefluxStop™ implantation
DeviceStandard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
Reduction of Patient Reported Outcome - Side effects (PROS)
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
Incidence of safety events
Safety events include: SADEs, SAEs, ADEs, procedure-related or unknown AEs and DDs
Reduction of Patient Reported Outcome - Side effects (PROS)
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
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