Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty

Popis výsledku v původním jazyce

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&apos; 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.

Název v anglickém jazyce

Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty

Popis výsledku anglicky

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&apos; 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Gastrointestinal endoscopy

ISSN

0016-5107

e-ISSN

1097-6779

Svazek periodika

101

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

106-"116.e1"

Kód UT WoS článku

001391126400001

EID výsledku v databázi Scopus

2-s2.0-85207731839