This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.
Willing and able to provide informed consent and to participate in the clinical investigation;
Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
Documented GERD present for ≥ 12 months. Typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain;
24-hour 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 time during a 24-hour monitoring);
> 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed;
Manometry verified lack of or moderate or severe weak peristalsis in esophagus with DCI <300 or pathologic LOS function including hypercontractability, spasm or pathologic nonrelaxing functionality (the latter defined as coordinated swallows in less than 70% of wet swallows or median IRP>15mmHg). Hypercontractability defined as DCI >8'000 or pressure >45 mmHg. Thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis;
History of bariatric or anti-reflux surgery;
Female subjects who are pregnant or nursing;
Parallel
RefluxStop™ implantation
DeviceStandard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
Nissen fundoplication
Procedure/SurgeryStandard surgical technique for Nissen fundoplication
Patient Reported Outcomes - Side effects (PROS) evaluation
Patient Reported Outcomes - Side effects (PROS) evaluation at 6 months, combining the well-established side effects of traditional surgical treatment methods: * Dysphagia - swallowing difficulties; * Odynophagia - pain at swallowing; * Inability to belch and inability to vomit; and * Worsening of gas bloating compared to baseline;
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This trial is not recruiting at the moment. You can still explore other options:
