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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm: intervention | Other | Single arm registry: all enrolled patients will be implanted with RefluxStopTM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RefluxStop™ implantation | Device | Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of safety events | Safety events include: SADEs, SAEs, ADEs, procedure-related or unknown AEs and DDs | 3 and 6 months and years 1 to 7 |
| Reduction of Patient Reported Outcome - Side effects (PROS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Friedrichshafen GmbH | Friedrichshafen | Germany |
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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
| 6 months and years 2 to 7 |
| 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 |
|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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