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임상시험 NCT07307547 (AI-COLOSCREEN)은(는) 대장 종양, 대장 폴립, 선종, 대장암에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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저장 대학Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN) 3,342 무작위 배정 다기관
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 NCT07307547 (AI-COLOSCREEN)은(는) 대장 종양, 대장 폴립, 선종, 대장암에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 4월 1일부터 참여 신청이 가능합니다. 3,342명의 참여자를 모집할 예정입니다. 저장 대학이(가) 진행하는 이 연구는 2028년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 10일에 갱신되었습니다.
간단한 개요
This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed...더 보기
상세한 설명
Colorectal cancer (CRC) screening is crucial for early detection and reducing mortality, yet current colonoscopy techniques face challenges such as variable adenoma detection rates (ADR) and the risk of missed diagnoses for subtle lesions. This study is a prospective, multi-center, parallel-group, randomized controlled trial aiming to validate the clinical value of an AI-assisted diagnostic system in improving screen...더 보기
공식 제목
A Multi-center, Randomized, Controlled Clinical Study on the Efficacy of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions.
질환명
대장 종양대장 폴립선종대장암기타 연구 식별자
- AI-COLOSCREEN
- 2025-0756
NCT 번호
실제 연구 시작일
2026-04
최신 업데이트 게시
2026-02-10
예상 연구 완료일
2028-12
계획된 등록 인원
3,342
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Artificial Intelligence
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
주요 목적
스크리닝 (선별)
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Experimental: AI-Assisted Colonoscopy Participants will undergo a high-definition colonoscopy procedure where a real-time artificial intelligence system analyzes the video feed to assist the endoscopist in identifying and highlighting suspicious lesions. | AI-Assisted Colonoscopy High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system. |
비개입Control: Conventional Colonoscopy Participants will undergo a standard high-definition colonoscopy procedure performed by a qualified endoscopist without the assistance of the artificial intelligence system. The AI software will not be active during these procedures. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Adenoma Detection Rate (ADR) | The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports. | From the day of the procedure up to 14 days post-procedure. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean Adenomas Per Colonoscopy (APC) | The mean number of histologically confirmed adenomas detected per participant. The number of polyps is counted during the procedure, but confirmation of adenoma status depends on pathology. | From the day of the procedure up to 14 days post-procedure. |
Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate | The proportion of participants with at least one histologically confirmed advanced adenoma (defined as ≥10mm, or with high-grade dysplasia or villous components) or SSA/P. | From the day of the procedure up to 14 days post-procedure. |
Patient Satisfaction Score | Assessed using a 5-point Likert scale questionnaire evaluating examination comfort and acceptance of the AI system (1=very unsatisfied, 5=very satisfied). | Assessed within 1 hour after completion of the colonoscopy procedure. |
Physician Satisfaction Score | Assessed using a 5-point Likert scale questionnaire evaluating the AI system's usability and reliability (1=very unsatisfied, 5=very satisfied). | Assessed within 1 hour after completion of the colonoscopy procedure. |
Incidence of Procedure-Related Adverse Events | The number and type of adverse events (AEs) and serious adverse events (SAEs), including but not limited to perforation, significant bleeding, and infection, are recorded. | From the start of the procedure up to 30 days post-procedure. |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Age between 18 and 75 years, inclusive.
- Scheduled for a screening, diagnostic, or surveillance colonoscopy.
- Able to understand the study protocol and provide written informed consent.
- Known contraindications to colonoscopy or biopsy.
- Personal history of colorectal cancer, inflammatory bowel disease (IBD), or previous colorectal surgery.
- Known or suspected colorectal polyposis syndrome (e.g., Familial Adenomatous Polyposis - FAP).
- Patients with active colorectal bleeding, bowel obstruction, or toxic megacolon.
- Women who are pregnant, planning to become pregnant, or are breastfeeding.
- Participation in another interventional clinical trial within the 30 days prior to enrollment.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
저장 대학연구 책임자
Ding Ke-Feng, 책임연구자, Clinical professor, Zhejiang University
연구 대표 연락처
연락처: Kefeng Ding, M.D., Ph.D., +86-13906504783, [email protected]
1 1개국에 임상시험 장소
Zhejiang
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Kefeng Ding, M.D., Ph.D., 연락처, +86-13906504783, [email protected]