Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Adenoma and Polyp Miss Rate
研究概览
简要总结
To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy.
To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
详细描述
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.
Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy. Subjects in Group B (control group) will undergo an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
Results from the two groups will be analyzed and compared, with primary outcome measures being adenoma miss rate and polyp miss rate. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
Multi-center study with up to 126 patients. Up to 126 treated patients (2 groups of 57 patients +6 drop-out patients) will be enrolled into the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject between the ages of 40 and 75
- •The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- •Written informed consent must be available before enrollment in the trial
排除标准
- •Patients with a history of colonic resection;
- •Patients with known (or newly diagnosed) inflammatory bowel disease;
- •Patients with a personal history of polyposis syndrome;
- •Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- •Patients with diverticulitis or toxic megacolon;
- •Patients with a history of radiation therapy to abdomen or pelvis;
- •Patients with a hemorrhagic diathesis
- •Patients with acute lower GI bleeding
- •Pregnant women and women with childbearing potential without adequate contraception
- •Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
研究组 & 干预措施
Group A
Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.
干预措施: Tandem Colonoscopy (Device)
Group B
Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:
an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
干预措施: Tandem Colonoscopy (Device)
结局指标
主要结局
Adenoma and Polyp Miss Rate
时间窗: 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.
Group A- we measured the Adenoma\&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings). Group B- we measured the Adenoma\&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard). Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group\]\*100
次要结局
- Sedation(During the procedure)
- Colon Area Screened(During the procedure)
- Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured(During the procedure)
- Total Number of Therapeutic Interventions Performed(Interventions during procedure)
- Scope Centering Ability(During the procedure)
- Patient Satisfaction(24 hours post procedure)