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임상시험 NCT07089615은(는) 대장 폴립들에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference 330 오픈 라벨

모집중
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07089615은(는) 대장 폴립들에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 6월 26일에 시작되어 330명의 참여자를 모집하고 있습니다. Capso Vision, Inc.이(가) 진행하며, 2026년 1월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 28일에 갱신되었습니다.
간단한 개요
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 u...

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

질환명
대장 폴립들
기타 연구 식별자
  • CLN-CVI-5794 2nd Generation
NCT 번호
NCT07089615
실제 연구 시작일
2025-06-26
최신 업데이트 게시
2025-07-28
예상 연구 완료일
2026-01
계획된 등록 인원
330
연구종류
중재연구
단계/상
해당 없음
상태
모집중
주요 목적
스크리닝 (선별)
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적A new capsule design is being used from that of the first phase of the study.
Capsule swallow
Participant will swallow the investigational device
주요결과변수
결과변수측정값 설명시간 범위
Positive Percentage Agreement
• 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.
From capsule swallow to Colonoscopy - up to 6 weeks
Negative Percentage Agreement
• 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.
From Capsule swallow to colonoscopy - Up to 6 weeks
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
45 Years
참여 가능한 성별
전체
  1. 45-75 years of age
  2. Committed to undergo a colonoscopy.
  3. Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

  1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
  2. Has contraindication for capsule endoscopy or colonoscopy
  3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
  4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
  5. History of incomplete colonoscopy
  6. 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).
  7. Impaired cardiac function assessed as greater than NYHA Class II
  8. History of small- or large-bowel obstructive condition
  9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
  10. 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
  11. Known allergy to ingredients used in bowel preparation and boosters
  12. Daily and/or regular narcotic use
  13. Decompensated cirrhosis
  14. Prior abdominal radiation therapy
  15. Diagnosis of anorexia or bulimia
  16. 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
  17. Known or suspected megacolon
  18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
  19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
  20. 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.
  21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
  22. 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
  23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
  24. Chronic constipation as defined by <3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
Capso Vision, Inc. logoCapso Vision, Inc.
연구 대표 연락처
연락처: Taylor Williamsen Principle CRA/Study Lead, 815-861-9575, [email protected]
연락처: Rebecca Petersen Sr. Director of Clinical Affairs, 510-566-8824, [email protected]
11 1개국에 임상시험 장소

California

SB Gastro Clinical Research, Chula Vista, California, 91910, United States
Study Coordinator, 연락처, 619-513-3372, [email protected]
Erick Alayo, M.D., 책임연구자
모집중
Gastro Care Institute, Lancaster, California, 93534, United States
Lead Study Coordinator, 연락처, 661-529-7550, [email protected]
Kumaravel Perumalsamy, M.D., 책임연구자
모집중
Knowledge Research Center, Orange, California, 92868, United States
Regulatory/Study Coordinator, 연락처, 657-247-0087, [email protected]
Alla Abousaif, M.D., 책임연구자
모집중

Florida

Advanced Research Institute, St. Petersburg, Florida, 33710, United States
Study Coordinator, 연락처, 727-835-3261, [email protected]
Jatin Bidani, M.D., 책임연구자
모집중

Illinois

Digestive Health Services, Downers Grove, Illinois, 60515, United States
Site Manager, 연락처, (708) 253-5810, [email protected]
Rockford Yapp, M.D., 책임연구자
모집중
Gastroenterology and Internal Medicine Specialists, Lake Barrington, Illinois, 60010, United States
Site Manager, 연락처, 708-253-5810, [email protected]
Nicole Gentile, M.D., 책임연구자
모집중
Northshore Center for Gastroenterology, Libertyville, Illinois, 60048, United States
Site Manager, 연락처, 708-253-5810, [email protected]
Sean Lee, M.D., 책임연구자
모집중
Suburban Gastroenterology, Naperville, Illinois, 60540, United States
Site Manager, 연락처, 708-253-5810, [email protected]
Thomas Couri, M.D., 책임연구자
모집중
Southwest Gastroenterology, Oak Lawn, Illinois, 60453, United States
Site Manager, 연락처, 708-253-5810, [email protected]
Kamran Ayub, M.D., 책임연구자
모집중

New York

Gastroenterology Group of Rochester, Rochester, New York, 14618, United States
Lead Study Coordinator, 연락처, 585-278-1116, [email protected]
Jonathan Wilmot, M.D., 책임연구자
모집중

Ohio

Great Lakes Gastroenterology Research, Mentor, Ohio, 44060, United States
Lead Clinical Research Coordinator, 연락처, 216-387-4966, [email protected]
Keith Friedenberg, M.D., 책임연구자
모집중