Boskoski Ivo, Lopez-Nava Gontrand, Ravishankar Asokkumar, Bove Vincenzo, Matteo Maria Valeria, De Siena Martina, Pontecorvi Valerio, Giannetti Giulia, Iaconelli Amerigo, Spada Cristiano, Shamah Steven E
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.
Bariatric Endoscopy Unit, HM Sanchinarro University Hospital, Madrid, Spain.
Gastrointest Endosc. 2025 Apr;101(4):818-827. doi: 10.1016/j.gie.2024.09.026. Epub 2024 Sep 21.
EndoZip (Nitinotes Ltd, Cesarea, Israel) is a fully automated, operator-independent robotic endoscopic suturing device developed for gastric volume reduction and treatment of obesity. We aim to assess the efficacy and safety of EndoZip to treat patients with obesity.
We conducted a prospective multicenter study and recruited 45 patients with a body mass index of 30 to 40 kg/m. Our primary outcome was to assess the percentage of total body weight loss (%TBWL) at 12 months. The secondary outcome was to determine the safety and change in quality of life using the Influence of Weight on the Quality of Life questionnaire at 1 year.
The mean ± standard deviation age was 44.2 ± 8.8 years, and the mean ± standard deviation body mass index was 34.5 ± 2.9 kg/m. A majority (90.7%) of patients were female. The procedure was technically successful in all patients (100%). A median of 4 (range, 3-5) full-thickness sutures were placed, and the mean procedure time was 30.8 ± 15.8 minutes. At 12 months, the mean %TBWL was 13.21 (95% confidence interval, 10.11-16.31), and 76.6% of patients achieved ≥5% TBWL. We observed significant reduction in waist circumference, glycated hemoglobin, and alanine aminotransferase levels at 12 months (P < .001). We found a significant improvement in quality of life at 12 months (51.28 ± 16.22 vs 35.8 ± 11.9, P < .001). Serious adverse events occurred in 2 patients (4.4%). The average length of stay was 1 day.
Our first-in-human study showed that the EndoZip device is safe and effective in treating obesity. The weight loss led to changes in comorbidities and improvement in quality of life. (Clinical trial registration number: NCT04773795.).
EndoZip（以色列凯撒利亚的Nitinotes有限公司）是一款全自动、无需操作人员干预的机器人内镜缝合设备，专为胃容积缩小和肥胖治疗而研发。我们旨在评估EndoZip治疗肥胖患者的疗效和安全性。
我们开展了一项前瞻性多中心研究，招募了45名体重指数为30至40kg/m的患者。我们的主要结局是评估12个月时总体重减轻百分比（%TBWL）。次要结局是使用生活质量受体重影响问卷在1年时确定安全性和生活质量变化。
平均年龄±标准差为44.2±8.8岁，平均体重指数±标准差为34.5±2.9kg/m。大多数（90.7%）患者为女性。该手术在所有患者中技术上均成功（100%）。放置的全层缝合线中位数为4（范围3 - 5），平均手术时间为30.8±15.8分钟。在12个月时，平均%TBWL为13.21（95%置信区间，10.11 - 16.31），76.6%的患者实现了≥5%的TBWL。我们观察到12个月时腰围、糖化血红蛋白和丙氨酸转氨酶水平显著降低（P < .001）。我们发现12个月时生活质量有显著改善（51.28±16.22对35.8±11.9，P < .001）。2名患者（4.4%）发生严重不良事件。平均住院时间为1天。
我们的首例人体研究表明，EndoZip设备治疗肥胖安全有效。体重减轻导致合并症的改变和生活质量的改善。（临床试验注册号：NCT04773795。）
