A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice
Condition(s) studied
Investigational drug(s) / intervention(s)
RefluxStop™ implantation: Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
Study 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.
Eligibility
Primary outcome measure(s)
- Reduction of Patient Reported Outcome - Side effects (PROS) — 1 year
Patient Reported Outcome - Side effects (PROS) combine the established side effects: Dysphagia, Odynophagia, Inability to Belch, Inability to Vomit, and worsened Gas bloating, compared to baseline
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Klinikum Friedrichshafen GmbH | Friedrichshafen | Germany | |
| H. Universitario Getafe | Getafe | Madrid | |
| H. La Mancha Centro | Alcázar de San Juan | Spain | |
| H. Infanta Sofía | Madrid | Spain | |
| H. Ramón y Cajal | Madrid | Spain |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07004439 on ClinicalTrials.gov ↗ ← All trials in Spain