NCT06916845已完成不适用
Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)
Capso Vision, Inc.8 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年3月16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
- 86
- 试验地点
- 8
- 主要终点
- Collect Capsule Images
研究概览
简要总结
The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol.
Participants will
- adhere to bowel prep instructions and dietary requirements
- ingest pro-kinetic medication and CapsoCam® Colon (CV-3E)
- adhere to booster regimen and dietary requirements until capsule passes
- retrieve capsule with retrieval kit per instructions and mail back to sponsor
- participate in follow-up phone call
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •45-75 years of age
- •Choose to participate and must have signed the IRB-approved informed consent document.
排除标准
- •Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
- •Colonoscopy within the past 4 years that demonstrated polyps that were removed.
- •Has contraindication for capsule endoscopy
- •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
结局指标
主要结局
Collect Capsule Images
时间窗: 4-6 months
No assessment will be done for this protocol. Videos will be collected for AI development for use in future study.
次要结局
未报告次要终点
研究者
研究点 (8)
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