EFFICACY OF THE SLEEVE GASTROPLASTY WITH THE ENDOSCOPIC SYSTEM OVERSTICH SX ON WEIGHT LOSS AND REDUCTION OF CO-MORBIDITY FOR OBESE PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
研究概览
简要总结
The OverStitch ™ Sx System (Apollo Endosurgery Inc., Austin, Tx, Usa) is a new generation of endoscopic suturing device. It is inserted into an endoscope allowing the approximation of Luc Karsentys soft tissue by placement of sutures. It is as effective a suture system as a surgical system. The OverStitch ™ Sx allows suturing in the upper and lower GI with a flexible single channel endoscope. Previously, the ™ Overstich was only compatible with an Olympus dual channel endoscope.
Thus, a wide range of interventions are possible, including gastric endoplastic sleeve (ESG), RYGB revision, anastomotic fistula repair and / or sleeve revision. In each of these indications, the OverStitch (OverStitch) ™ system has shown its effectiveness and safety.
The OverStitch Endoscopic ™ Suture System allows the entire digestive wall to be sutured through a flexible endoscope. Thus, a wide range of interventions are possible, including gastric pocket repair after gastric bypass surgery, anastomotic fistula repair, endoscopic treatment of digestive perforation, and endoscopic sleeve surgery. In each of these indications, the OverStitch system has demonstrated its effectiveness and safety. But this technique is recent, especially in France. In addition, no data has yet been released regarding the new Overstitch ™ Sx device compatible with all single channel endoscopes.
An observational study including patients in French centers that are experts in therapeutic endoscopy seems essential to us to better assess this new device and this new technique in practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18, male or female
- •Patient with obesity with a BMI> 30 or BMI> 40 (if surgery contraindicated or refused by the patient)
- •Patient with a weight gain after sleeve gastroplasty or sleeve gastrectomy
- •Informed and written consent of the patient obtained
- •Complete clinical examination
- •Lack of participation in another clinical study
- •Patient able to follow, understand the study and answer the questionnaire
排除标准
- •Haemorrhagic disease, haemostasis and coagulation disorder and platelets <60000 / mm3).
- •Breastfeeding women
- •Toxicomany, alcoolism
- •Patient known for gastric lesion requiring surveillance or familial history of gastric neoplasia
- •Hiatus hernia> 4 cm high
结局指标
主要结局
For the endoscopic sleeve: by the rate of patients with a percentage of total weight lost
时间窗: 12 MONTHS
次要结局
- For sleeve revision, by the rate of patients with a percentage of total weight lost(12 MONTHS)
- Evaluation of safety Immediate morbidity(DAY 1)