Performance Evaluation of the NaviAid™ G-Eye System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 8
- 主要终点
- NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate
研究概览
简要总结
The purpose of this study is to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.
详细描述
Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.
The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.
A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.
This is a multicenter, two-arm, randomized, open-label study intended to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.
Subjects will be randomized to one of two groups: Group A, the "Study Group," and Group B, the "Control Group."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- •The patient is over 40 years old;
- •The patient must understand and provide written consent for the procedure.
排除标准
- •Subjects with inflammatory bowel disease;
- •Subjects with a personal history of polyposis syndrome;
- •Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- •Subjects with diverticulitis or toxic megacolon;
- •Subjects with a history of radiation therapy to abdomen or pelvis;
- •Pregnant or lactating female subjects;
- •Subjects who are currently enrolled in another clinical investigation.
- •Subjects with routine oral or parenteral use of anticoagulants
- •Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- •Any patient condition deemed too risky for the study by the investigator
研究组 & 干预措施
A-Standard Colonoscopy, G-Eye procedure
Standard Colonoscopy,G-Eye procedure
干预措施: Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure (Procedure)
B- G-Eye procedure, Standard Colonoscopy
G-Eye procedure,Standard Colonoscopy
干预措施: Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy (Procedure)
结局指标
主要结局
NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate
时间窗: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure
次要结局
未报告次要终点