Please use this identifier to cite or link to this item: http://hdl.handle.net/10553/111392
Title: Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study
Authors: Lopez-Nava, Gontrand
Asokkumar, Ravishankar
Rull, Angel
Fernandez-Corbelle
Bautista Castaño, Inmaculada 
Dayyeh, Barham Abu
UNESCO Clasification: 32 Ciencias médicas
320503 Gastroenterología
3213 Cirugía
Keywords: Automatic suturing
Bariatric endoscopy
Endoscopic gastroplasty
EndoZip
Obesity, et al
Issue Date: 2020
Journal: Obesity Surgery 
Abstract: Introduction: Endoscopic gastroplasty and gastric volume reduction techniques have been shown to achieve significant weight loss and improvement in comorbid conditions. The objective of this study is to assess the feasibility and safety of a novel fully automated, operator-independent endoscopic suturing system (EndoZip™) for minimally invasive treatment of obesity. Design: Single-center pilot feasibility study. Patients: Eleven patients with a body mass index (BMI) of 30 to 40 kg/m2 with or without obesity-associated comorbidity. Interventions: Gastric volume reduction with EndoZip™ system. Main Outcome Measurements: Primary outcome was to assess the technical feasibility and safety. The secondary outcome was to determine %total body weight loss (TBWL) and %excess weight loss (EWL) at 6 months. Results: The mean ± SD age was 42.7 ± 5.6 years, and the mean ± SD BMI was 36.9 ± 2.8 kg/m2. A majority (64%) were men. The procedure was technically successful (100%) in all patients. A median of 3 (range, 2–4) full-thickness sutures were placed, and the mean procedure time was 54.6 ± 23.9 (23–100) min. No immediate complications occurred, and all were discharged in 24 h. One patient developed respiratory infection 3 days after the procedure and required hospitalization. The infection was mild and resolved with antibiotic treatment. At 6-month follow-up, the mean ± SD TBWL, %TBWL, and %EWL were 17.8 ± 6.7 kg, 16.2 ± 6.0%, and 54.3 ± 28.4%, respectively (p < 0.001). Limitations: Limited number of patients. Conclusion: Our first-in-human study showed that the Endozip™ device could be safely used for the treatment of obesity. The early weight loss results are promising. An extended feasibility study on a larger sample size is being planned (Clinicaltrials.gov. NCT03472196).
URI: http://hdl.handle.net/10553/111392
ISSN: 0960-8923
DOI: 10.1007/s11695-019-04370-w
Source: Obesity Surgery [ISSN 0960-8923], n. 30, p. 1696–1703
Appears in Collections:Artículos
Show full item record

SCOPUSTM   
Citations

10
checked on May 19, 2024

Page view(s)

41
checked on Nov 25, 2023

Google ScholarTM

Check

Altmetric


Share



Export metadata



Items in accedaCRIS are protected by copyright, with all rights reserved, unless otherwise indicated.