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A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice
Sponsor: Implantica CE Reflux Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-09-15
Completion Date
2035-08-01
Last Updated
2025-06-04
Healthy Volunteers
No
Conditions
Interventions
RefluxStop™ implantation
Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
Locations (5)
Klinikum Friedrichshafen GmbH
Friedrichshafen, Germany
H. Universitario Getafe
Getafe, Madrid, Spain
H. La Mancha Centro
Alcázar de San Juan, Spain
H. Infanta Sofía
Madrid, Spain
H. Ramón y Cajal
Madrid, Spain