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Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark
BACKGROUND: RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy,...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370422/ https://www.ncbi.nlm.nih.gov/pubmed/32689979 http://dx.doi.org/10.1186/s12893-020-00794-9 |
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author | Bjelović, Miloš Harsányi, László Altorjay, Áron Kincses, Zsolt Forsell, Peter |
author_facet | Bjelović, Miloš Harsányi, László Altorjay, Áron Kincses, Zsolt Forsell, Peter |
author_sort | Bjelović, Miloš |
collection | PubMed |
description | BACKGROUND: RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS: In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for 1 year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-h pH monitoring, and reduction in average daily PPI usage and subject satisfaction. RESULTS: There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p < 0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH < 4 from 16.35 to 0.80% at the 6-month visit (p < 0.001), with 98% of subjects showing normal 24-h pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION: The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02759094. Registered 3 May, 2016, |
format | Online Article Text |
id | pubmed-7370422 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-73704222020-07-21 Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark Bjelović, Miloš Harsányi, László Altorjay, Áron Kincses, Zsolt Forsell, Peter BMC Surg Research Article BACKGROUND: RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS: In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for 1 year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-h pH monitoring, and reduction in average daily PPI usage and subject satisfaction. RESULTS: There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p < 0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH < 4 from 16.35 to 0.80% at the 6-month visit (p < 0.001), with 98% of subjects showing normal 24-h pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION: The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02759094. Registered 3 May, 2016, BioMed Central 2020-07-20 /pmc/articles/PMC7370422/ /pubmed/32689979 http://dx.doi.org/10.1186/s12893-020-00794-9 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Bjelović, Miloš Harsányi, László Altorjay, Áron Kincses, Zsolt Forsell, Peter Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark |
title | Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark |
title_full | Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark |
title_fullStr | Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark |
title_full_unstemmed | Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark |
title_short | Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: RefluxStop™ device; a new method in acid reflux surgery obtaining CE mark |
title_sort | non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results: refluxstop™ device; a new method in acid reflux surgery obtaining ce mark |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370422/ https://www.ncbi.nlm.nih.gov/pubmed/32689979 http://dx.doi.org/10.1186/s12893-020-00794-9 |
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