Clinical Trial

A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice

Study acronym: RESTORE500
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07004439
Lead Sponsor Implantica CE Reflux Ltd.
Conditions Gastroesophageal Reflux Disease
Enrollment 500 participants
Start Date 2025-09-15
Primary Completion 2029-08-01 (estimated)
Study Completion 2035-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-04