Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of Gastroesophageal Reflux Disease (GERD)

Status: Active, not recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Subject's age >= 18 years and <= 75 years

• Subject is able to undergo general anaesthesia and is a suitable laparoscopic surgical candidate

• Subject is willing and able to participate

• Subject has provided written informed consent after being informed of the study procedure and risks prior to any study-related events

• Subject has documented typical GERD symptoms present for > 6 months which respond to PPIs as anti-GERD medication. Typical symptom of GERD is defined as heartburn, which is a burning epigastric or substernal pain

• Subject requires daily PPI anti GERD medication

• Subject has a 24-hour pH monitoring proven GERD performed taken off any anti reflux medication or after discontinuation for at least 7 days prior to testing. Total distal esophageal pH must be <= 4 for >= 4.5% if time during a 24-hour monitoring

Locations
Other Locations
Hungary
Semmelweis University
Budapest
University of Debrecen, Kenezy Gyula Teaching Hospital, General Surgery Department
Debrecen
Fejer County Szent Gyorgy University Teaching Hospital, Surgical Department
Székesfehérvár
Serbia
Clinical Center of Serbia, Clinic for Digestive Surgery
Belgrade
Time Frame
Start Date: December 2016
Estimated Completion Date: December 2022
Participants
Target number of participants: 50
Treatments
Experimental: Treatment with RefluxStop device
All enrolled subjects will receive treatment for their GERD using the RefluxStop device intervention
Sponsors
Leads: Implantica CE Reflux Ltd.

This content was sourced from clinicaltrials.gov

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