Trial reportSurgical endoscopy2024
Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study.
Trial report in Surgical endoscopy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
12 citing papers in PubMed.
- Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: a prospective multicenter trial of safety and effectiveness.Surgical endoscopy · 2025Trial
- Food passageway-related sequelae in the RefluxStop prospective multicenter trial: patient-centric outcomes of dysphagia, odynophagia, gas-bloating, and inability to belch and/or vomit at 5 years.Surgical endoscopy · 2025Trial
- Conversion from failed antireflux surgery to RefluxStop: A multicenter feasibility, technical evaluation, safety, and effectiveness study with 30 consecutive cases.Langenbeck's archives of surgery · 2026Article
- Safety outcomes in 602 GERD patients treated by RefluxStop: a multi-center real-world study from 22 centers across six European countries.Scientific reports · 2026Article
- Cost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective.BMC gastroenterology · 2026Article
- Gatherings in Esophagology: Innovations and Future Directions in the Diagnosis and Management of Reflux Disease.Annals of the New York Academy of Sciences · 2026Article
- Cost-Effectiveness of RefluxStop Versus Nissen Fundoplication and Proton Pump Inhibitors for Refractory Gastroesophageal Reflux Disease: A Spanish Healthcare Perspective.PharmacoEconomics - open · 2026Article
- A Historical and Scientific Review of Anti-Reflux Surgery: Evolution, Evidence, and Future Directions.Current gastroenterology reports · 2026Review
- Current pharmacological and procedural treatments for gastro-oesophageal reflux disease: comprehensive review.BJS open · 2025Review
- Therapeutic Management of Gastroesophageal Reflux Disease (GERD)-Is There Something Between PPI and Fundoplication? An Overview.Journal of clinical medicine · 2025Review
- A retrospective study assessing RefluxStop surgery for gastroesophageal reflux disease: Clinical outcomes in 79 patients from Germany.Surgery open science · 2025Article
- Improving treatment of people with gastro-esophageal reflux disease refractory to proton pump inhibitors.Communications medicine · 2024Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device.
methodsA prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD.
resultsAvailable data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux.
conclusionThese results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop's dynamic physiologic interaction and non-encircling nature.
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