A Randomized Controlled Trial to Demonstrate the Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures for Diagnosis and Treatment in the Small Intestine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 123
- 试验地点
- 10
- 主要终点
- Device Superiority
研究概览
简要总结
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.
详细描述
The study objective, demonstrate superiority of the Aspero Ancora-SB balloon overtube compared to the Olympus ST-SB1 Balloon Overtube, is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers. Investigators propose to recruit patients scheduled for enteroscopy and use capsule endoscopy to identify patients with lesions in the middle third of the small bowel. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent;
- •Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
- •≥ 18 years of age to ≤ 90 years of age;
- •Video capsule endoscopy identified lesions in the middle third of the small bowel;
- •Willing and able to comply with all study procedures and follow-up.
排除标准
- •History of gastric bypass or related procedures;
- •History of foregut and/or midgut surgery;
- •Pathology identified by video capsule is in the proximal 1/3 of the bowel;
- •Pathology identified by video capsule is in the distal 1/3 of the bowel;
- •Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
- •Capsule endoscopy did not show clear visualization of pathology in the middle small bowel;
- •Inability to tolerate the investigator's method of sedation that is the standard of care;
- •Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy;
- •Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication;
- •Life expectancy < six (6) months.
结局指标
主要结局
Device Superiority
时间窗: Enteroscopy Procedure
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube. Superiority of the Ancora-SB Balloon Overtube will be demonstrated if it achieves a success rate of ≥75% compared to a success rate of 50% with the Olympus ST-SB1 Balloon Overtube.
次要结局
未报告次要终点