Publication date: Jul 22, 2025
RefluxStop surgery corrects all three components of the anti-reflux barrier without affecting the food passageway. Long-term 5-year safety and effectiveness clinical outcomes are presented from the RefluxStop CE mark trial, used in an FDA PMA submission. This comprehensive and meticulously controlled data are, therefore, presented across multiple reports with other outcomes in a separate complementary article. A prospective, single-arm, multicenter clinical study was conducted to investigate RefluxStop surgery in 50 adults with chronic GERD, PPI use, GERD-HRQL score, 24-h pH testing, contrast-swallow x-ray, and serious/non-serious AEs presented. Forty-four (n = 44) subjects completed 5-year follow-up, whereof 91% underwent pH testing and contrast-swallow x-ray. Three subjects were withdrawn due to COVID-19 (two deaths and one long-COVID), all well-treated beforehand, at 3-4 years. PPI usage (including COVID-19 subjects) in 1/47 (2. 1%). The median (IQR) total GERD-HRQL score improved by 90% (72-98%) from a baseline of 29. 5 (33. 0-24. 0) to 3. 0 (0. 5-7. 5) at 5 years (p
| Concepts | Keywords |
|---|---|
| 5years | 24-h pH monitoring |
| Fda | Antireflux surgery |
| Food | Dysphagia |
| Iqr | Gastroesophageal reflux disease |
| Surgery | Proton pump inhibitors |
| Quality of life |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | GERD |
| disease | MESH | COVID-19 |
| disease | MESH | Dysphagia |
| disease | IDO | quality |