Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImplantica CE Reflux Ltd.
About this trial
This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.
Eligibility criteria
Qualifiers
Willing and able to provide informed consent and to participate in the registry study,
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 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 and/or total reflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)
Disqualifiers
Presence of para-esophageal hernia or sliding hernia > 3 centimeters,
Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
History of bariatric surgery wherein the stomach fundus has been extirpated,
Female patients who are pregnant or nursing,
Trial design
Treatments tested in this trial
- RefluxStop implantation
- Nissen fundoplication
Treatment groups
2,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov