Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

Официальное название

Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

Обзор

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: 1. prep for and swallow a study capsule and then 2. prep for and undergo a colonoscopy either the following day or 3-6 weeks later

Вмешательства

• Устройство Capsule swallow
  Participant will swallow the investigational device

Первичные конечные точки

• Positive Percentage Agreement [Срок оценки: From capsule swallow to Colonoscopy - up to 6 weeks]
• Negative Percentage Agreement [Срок оценки: From Capsule swallow to colonoscopy - Up to 6 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 11 центров

• SB Gastro Clinical Research — Chula Vista
• Gastro Care Institute — Lancaster
• Knowledge Research Center — Orange
• Advanced Research Institute — St. Petersburg
• Digestive Health Services — Downers Grove
• Gastroenterology and Internal Medicine Specialists — Lake Barrington
• Northshore Center for Gastroenterology — Libertyville
• Suburban Gastroenterology — Naperville
• … и ещё 3 центра

Идентификаторы

NCT: NCT07089615 · CLN-CVI-5794 2nd Generation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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