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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
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
Reduction of Patient Reported Outcome - Side effects (PROS)
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
Time frame: 1 year
Incidence of safety events
Safety events include: SADEs, SAEs, ADEs, procedure-related or unknown AEs and DDs
Time frame: 3 and 6 months and years 1 to 7
Reduction of Patient Reported Outcome - Side effects (PROS)
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
Time frame: 6 months and years 2 to 7
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Madrid, Spain