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Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study

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ARTICLE DOWNLOAD

Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study

10$

Gontrand Lopez-Nava, Ravishankar Asokkumar, Angel Rull, Fernandez-Corbelle, Inmaculada Bautista & Barham Abu Dayyeh 

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).

Only units of this product remain
Year 2020
Language English
Format PDF
DOI 10.1007/s11695-019-04370-w