Phase
Condition
Gastroesophageal Reflux Disease (Gerd)
Heartburn (Pediatric)
Non-ulcer Dyspepsia (Nud)
Treatment
Nissen fundoplication
RefluxStop implantation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing and able to provide informed consent and to participate in the registrystudy,
Patient's age ≥ 18 years or according to local legal age of adulthood if older,
Documented GERD present for > 6 months,
Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance pHmeasurement, off PPI therapy for at least 7 days prior to testing. (Total distalesophageal pH must be <4 for >4.5% of time during a 24-hour monitoring and/or totalreflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)
Suitable to undergo general anesthesia and is a suitable laparoscopic surgerycandidate as determined by the investigator.
Exclusion
Exclusion criteria:
Presence of para-esophageal hernia or sliding hernia > 3 centimeters,
Known presence of delayed gastric emptying, if no other cause for acid reflux couldbe diagnosed,
History of bariatric surgery wherein the stomach fundus has been extirpated,
Female patients who are pregnant or nursing,
Known sensitivity or allergies to silicone materials,
Intraoperative findings determined by the investigator that may result inunfavorable conduct of the registry study procedure (as outlined in the IFU);
Patients that are unable to comply with the registry study requirements, (forexample due to major psychiatric disorder or are considered otherwise unsuitable forparticipation in the registry study according to the investigator's judgement).
Study Design
Connect with a study center
Klinikum Friedrichshafen GmbH
Friedrichshafen, 88048
GermanySite Not Available
Mathilden Hospital
Herford, 32052
GermanySite Not Available
Ospedale IRCCS Saverio De Bellis
Bari, 70013
ItalyActive - Recruiting
Ospedale Buon Consiglio Fatebenefratelli
Napoli, 80123
ItalyActive - Recruiting
Akershus Universitetssykehus HF
Lørenskog, 1478
NorwayActive - Recruiting
Hirslanden Klinik
Bern, 3013
SwitzerlandActive - Recruiting
Inselspital, Universitätsspital Bern
Bern, 3010
SwitzerlandActive - Recruiting
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