Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty.
Journal
Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505
Informations de publication
Date de publication:
02 Jul 2024
02 Jul 2024
Historique:
received:
01
08
2023
revised:
17
02
2024
accepted:
30
06
2024
pubmed:
5
7
2024
medline:
5
7
2024
entrez:
4
7
2024
Statut:
aheadofprint
Résumé
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. 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. 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/m ESG is safe and effective, thus offering a satisfactory therapeutic option for a wide range of obese patients on a large scale.
Sections du résumé
BACKGROUND AND AIMS
OBJECTIVE
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
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
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/m
CONCLUSIONS
CONCLUSIONS
ESG is safe and effective, thus offering a satisfactory therapeutic option for a wide range of obese patients on a large scale.
Identifiants
pubmed: 38964484
pii: S0016-5107(24)03336-4
doi: 10.1016/j.gie.2024.06.041
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosure The following authors disclosed financial relationships: S.F. Vadalà di Prampero: proctor of the Overstitch device, the Endomina device, and the POSE-2 procedure; M. Bulajic: teaching expert (proctor) of the Overstitch device (Apollo Endosurgery/Boston Scientific), the Endomina device (Endo Tools Therapeutics), and the POSE-2 procedure (USGI Medical); L. Leclercq clinical affairs employee of Endotools Therapeutics; C. Spada: consultant for Medtronic and AnX Robotics, and speaker fees from Olympus and Pentax; I. Boskoski: consultant for Apollo Endosurgery, Boston Scientific, Nitinotes, Pentax, Cook Medical, Microtech, ERBE, and Endo Tools Therapeutics. All of the other authors disclosed no financial relationships.