NCT04246632已完成不适用
Prospective, Open Label, Pilot Study of the CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
Capso Vision, Inc.6 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2020年1月25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
- 112
- 试验地点
- 6
- 主要终点
- Efficacy Assessments
研究概览
简要总结
This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.
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
盲法说明
PI is masked to Capsule results and capsule reader is masked to colonoscopy results.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 50 and 75 years old
- •Subject meets at least one of the following criteria for increased risk for polyps:
- •Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test
- •Older than 55 years of age, without prior history of colonoscopy
- •Has had a positive colonoscopy ≥ 5 years prior to screening visit
- •And/or having at least two of the following risk factors:
- •Current smoker
- •BMI of ≥30
- •Family history (blood relative) of colorectal cancer
- •Sedentary lifestyle
- •Low fiber/ high fat diet
- •No contraindication for capsule endoscopy or colonoscopy
- •Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
- •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
- •History of negative colonoscopy within the last 10 years
- •History of incomplete colonoscopy
- •Impaired cardiac function assessed as greater than NYHA Class II
- •History of small- or large-bowel obstructive condition
- •Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease 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 patient at greater risk for capsule endoscope retention
- •Unable to follow or tolerate fasting, bowel preparation, and other study procedures
- •Known allergy to ingredients used in bowel preparation and boosters
- •Daily and/or regular use of narcotics
- •Known or suspected AIDS
- •Uncompensated cirrhosis
- •Prior abdominal radiation therapy
- •Diagnosis of anorexia or bulimia
- •History of or suspicion for: strictures, volvulus or intestinal obstruction; internal hernias or abdominal surgeries that the Investigator considers as an exclusion
- •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. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening.
- •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
- •Are currently enrolled in, or participated in within the last 30 days, another clinical study
- •Chronic constipation as defined by <3 bowel movements per week for at least 3 months prior to Screening, or the use of routine laxatives (other than fiber) to attain r regular bowel movements for at least 3 months prior to Screening
- •History of diabetes in which the prolonged fasting schedule could impose additional safety risks, as determined by the investigator
结局指标
主要结局
Efficacy Assessments
时间窗: Day 1
Determine the Accuracy of CapsoCam® to detect and measure size of colon polyps relative to the colonoscopy procedure.
次要结局
- Safety Assessments: Incidence of device related serious adverse events (SAEs) and unanticipated adverse device effects (UADEs)(Day 1-3)
研究者
研究点 (6)
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