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Prospective, single-arm multicenter, international, observational postmarket study to assess the safety and efficacy of a triangulation platform for treating patients requiring endoscopic gastroplasty
MV. Matteo, V. Pontecorvi, V. Bove, T. Hucl, G. Petranova, P. Drastich, SF. Vadalà di Prampero, I. Bassu, M. Bulajic, L. Leclercq, C. Spada, I. Boskoski
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
- MeSH
- dospělí MeSH
- gastroplastika * metody škodlivé účinky MeSH
- gastroskopie metody MeSH
- hmotnostní úbytek MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- morbidní obezita chirurgie MeSH
- obezita chirurgie komplikace MeSH
- pooperační komplikace MeSH
- postmarketingový dozor * MeSH
- prospektivní studie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
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 = 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.
Citace poskytuje Crossref.org
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- $a Matteo, Maria Valeria $u Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Roma, Italy; Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore, 00168 Roma, Italy
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- $a 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 = 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.
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