Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 22
- 主要终点
- Positive Percentage Agreement
研究概览
简要总结
Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied.
The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers. It will use colonoscopy results as a reference.
The participant will:
- prep for and swallow a study capsule and then
- prep for and undergo a colonoscopy either the following day or 3-6 weeks later
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •45-75 years of age
- •Committed to undergo a colonoscopy.
- •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 of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (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
研究组 & 干预措施
A new capsule design is being used from that of the first phase of the study.
干预措施: Capsule swallow (Device)
结局指标
主要结局
Positive Percentage Agreement
时间窗: From capsule swallow to Colonoscopy - up to 6 weeks
• Positive Percent Agreement (PPA) of the study device 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 ≥ 6 mm, 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.
Negative Percentage Agreement
时间窗: From Capsule swallow to colonoscopy - Up to 6 weeks
• Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
次要结局
未报告次要终点