Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F25%3A00085344" target="_blank" >RIV/00023001:_____/25:00085344 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S0016510724033364?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0016510724033364?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.gie.2024.06.041" target="_blank" >10.1016/j.gie.2024.06.041</a>
Alternative languages
Result language
angličtina
Original language name
Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty
Original language description
Background and Aims: Gastric restriction techniques have recently emerged as minimally invasive bariatric procedures. Endoscopic sutured gastroplasty (ESG) with the Endomina (Endo Tools Therapeutics, Gosselies, Belgium) triangulation platform proved to be safe and effective for the treatment of class I and II obesity in prospective studies. In this registry, we aimed to further assess on a larger scale the safety and efficacy of the procedure in routine practice with a dedicated device. Methods: This was a multicenter, observational, prospective post-market study including patients with obesity undergoing Endomina ESG. The primary safety outcome was the occurrence of serious adverse device effects (SADEs) at 12 months. The primary efficacy outcome was the technical success defined by completing the procedure without premature abortion owing to technical issues. The rates of procedure-related adverse events, weight loss outcomes, and quality of life changes were collected. Results: A total of 142 patients underwent ESG in 3 centers from July 2020 to March 2023. Of these, 67 (mean body mass index, 38.5 +/- 6.3 kg/m2) reached at least 12 months of follow-up up to October 2022. Technical success was 100%. No SADEs occurred. Seven mild procedure-related adverse events were reported overall. Mean percentage of excess weight loss and total body weight loss at 12 months' follow-up were 48.5% +/- 38.6 and 15.3% +/- 10.6, respectively (n Z 67). Improved quality of life was observed following ESG. Conclusions: ESG is safe and effective, thus offering a satisfactory therapeutic option for a wide range of obese patients on a large scale.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30219 - Gastroenterology and hepatology
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Gastrointestinal endoscopy
ISSN
0016-5107
e-ISSN
1097-6779
Volume of the periodical
101
Issue of the periodical within the volume
1
Country of publishing house
US - UNITED STATES
Number of pages
12
Pages from-to
106-"116.e1"
UT code for WoS article
001391126400001
EID of the result in the Scopus database
2-s2.0-85207731839