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NOT YET RECRUITING
NCT07004439
NA

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.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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