NCT07004439

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

A Post-market Registry Study Based on Standard Clinical Care to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Implantica CE Reflux Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DEVICE	RefluxStop™ implantation	Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use

Timeline

• Start date: 2025-09-15
• Primary completion: 2029-08-01
• Completion: 2035-08-01
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

5 sites across 2 countries: Germany, Spain