NCT04607746已完成不适用
Prospective Open Label, Pivotal Study of the Accuracy of The CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Capso Vision, Inc.44 个研究点 分布在 1 个国家目标入组 1,337 人开始时间: 2021年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,337
- 试验地点
- 44
- 主要终点
- Positive Percent Agreement/Negative Percent Agreement
研究概览
简要总结
This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.
详细描述
The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 45-75 years of age
- •Committed to undergo a colonoscopy, independent of this study
- •Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor
排除标准
- •Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
- •Has contraindication for capsule endoscopy or colonoscopy
- •Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
- •Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- •History of incomplete colonoscopy
- •Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within the past 3 months and/or with history of constipation or gastroparesis.)
- •Impaired cardiac function assessed as greater than NYHA Class II
- •History of small- or large-bowel obstructive condition
- •Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
- •Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the subject at greater risk for capsule endoscope retention
- •Known allergy to ingredients used in bowel preparation and boosters
- •Daily and/or regular narcotic use
- •Decompensated cirrhosis
- •Prior abdominal radiation therapy
- •Diagnosis of anorexia or bulimia
- •History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation
- •Known or suspected megacolon
- •Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
- •Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
- •Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. WOCBP must have a negative urine pregnancy test at screening.
- •Unable to follow or tolerate fasting, bowel preparation, and other study procedures
- •Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results
- •Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
- •Chronic constipation as defined by <3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
结局指标
主要结局
Positive Percent Agreement/Negative Percent Agreement
时间窗: 6 weeks
1. Positive Percent Agreement (PPA) of study device (SD) with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is \>= 6mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment. 2. Negative percent agreement (NPA) of the SD with CADe for not detecting any polyp \>= 6mm in a subject for whom OC did not detect any polyp \>=6mm.
次要结局
- Positive Percent Agreement/Negative Percent Agreement--secondary(6 weeks)
研究者
研究点 (44)
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