임상 레이더 AI | ||
|---|---|---|
임상시험 NCT06792292 (Delta-AI)은(는) 인공지능, 대장 선종, 대장 신생물들, 대장 폴립, 대장내시경에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital (Delta-AI) 765
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 NCT06792292 (Delta-AI)은(는) 인공지능, 대장 선종, 대장 신생물들, 대장 폴립, 대장내시경에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2025년 2월 1일부터 참여 신청이 가능합니다. 765명의 참여자를 모집할 예정입니다. Chirec이(가) 진행하는 이 연구는 2027년 6월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 1월 24일에 갱신되었습니다.
간단한 개요
Cancer can develop in the colon, or large bowel. Examination of the colon with a tube fitted with a camera is called a colonoscopy.
Colonoscopy allows detection of small growths in the colon, called "polyps". Polyps can often be removed during colonoscopy. Some of these polyps are called adenomas and can become cancer after several years.
A good colonoscopy aims to find and take out as many of these polyps as possi...
더 보기상세한 설명
The colon is a part of the bowel where colon cancer can develop.
It is possible to prevent colon cancer by doing a screening test called a colonoscopy.
The colonoscopy procedure allows detection of "polyps" which can often be removed during the procedure. Some of these polyps are called adenomas and can become cancer after several years.
A good colonoscopy aims to find and take out as many of these polyps as possi...
더 보기공식 제목
Real-World Experience of Artificial Intelligence-Assisted Colonoscopy in Colorectal Cancer Screening in a General Hospital: A Single-Center Cohort Phase IV Study
질환명
인공지능대장 선종대장 신생물들대장 폴립대장내시경출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- Delta-AI
- 2024 Chirec Delta Colo-AI
NCT 번호
실제 연구 시작일
2025-02-01
최신 업데이트 게시
2025-01-24
예상 연구 완료일
2027-06-01
계획된 등록 인원
765
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
colo-rectal cancer screening
artificial intelligence assisted colonoscopy
artificial intelligence assisted colonoscopy
주요 목적
진단
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군CCP: conventional colonoscopy procedure The conventional colonoscopy arm subjects will undergo a screening colonoscopy without assistance from artificial intelligence. | conventional colonoscopy procedure Study subjects in this interventional arm will undergo conventional colonoscopy. |
활성 대조군ACP: artificial intelligence-assisted colonoscopy procedure The artificial intelligence-assisted colonoscopy arm subjects will undergo a screening colonoscopy with assistance from an artificial intelligence module. | artificial intelligence-assisted colonoscopy procedure Study subjects in this interventional arm will undergo colonoscopy done with a commercially-available module that uses artificial intelligence to highlight suspected polyps on the screen during colonoscopy. This module also attempts to characterize the detected polyp as adenomatous or not. The detection and characterization of polyps is in real time, during the procedure. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Adenoma Detection Rate in Conventional versus Artificial Intelligence-Assisted Colonoscopy | The main objective of this study is the difference in the detection rate of colorectal adenomas in individuals over 45 years old during colonoscopies for colon cancer screening between a conventional colonoscopy procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 day |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The difference in the detection rate of colorectal adenomas according to size by group (5 mm/6-9 mm/>10 mm) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | Detection rate of diminutive, small, and large polyps will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 day |
The difference in the detection rate of colorectal adenomas according to the number per group (n=1-2/n= 3-10/n >10) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | The number of adenomas detected during the procedure will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 day |
The difference in the detection rate of colorectal adenomas based on histology by group (hyperplastic/conventional adenomas/serrated adenomas/adenocarcinoma) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI. | Adenomas have different histologic types. After obtaining histology, the detection rate of the various histologic types will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 month |
The difference in detection rate of colorectal adenomas based on dysplastic grade by group | The difference in detection rate of colorectal adenomas based on dysplastic grade
by group (conventional or serrated adenomas/low-grade dysplasia/high-grade dysplasia/adenocarcinoma) or Narrow Band Imaging International Colorectal Endoscopic (NICE) (stages 1, 2 or 3) classification or Japan Narrow Band Imaging Expert Team (JNET) classification (stages 1, 2A and 2B, or 3) between a conventional colonoscopy procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 day |
The difference in the detection rate of colorectal adenomas depending on the location by group (rectum/left colon/transverse colon/right colon) between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | Location of adenomas will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 day |
The difference in the detection rate of colorectal adenomas according to experience by group of colonoscopists | The difference in the detection rate of colorectal adenomas according to experience by group (Colonoscopists aged 45-55 years/56-65 years/\>66 years) between a conventional colonoscopic procedure (CCP) and a conventional colonoscopic procedure (CCP) colonoscopy with AI (ACP). | 1 day |
The difference in the detection rate of colorectal adenomas depending on the time of day . | The difference in the detection rate of colorectal adenomas depending on the time of day (before 11:00/between 11:00 and 15:00/after 15:00) and the number of colonoscopies (Colonoscopy from 1 to 6 per half-day) per group (hyperplastic/conventional adenomas/scalloped adenomas/adenocarcinoma) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI (ACP). | 1 day |
The difference in the detection rate of colorectal adenomas according to colonic preparation by group (Boston Score 9/6-8/<6) between a conventional colonoscopic procedure (PCC) and a colonoscopy procedure with AI (ACP). | The difference in the adenoma detection rate according to the quality of colonic preparation will be compared between a conventional colonoscopic procedure (CCP) and a colonoscopy procedure with AI (ACP). | 1 day |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
45 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Patient (woman or man) candidate for a screening colonoscopy - Age: 45 to 74 years included
- Absence of inflammatory bowel disease
- Absence of significant digestive symptoms indicating colonoscopy (i.e. screening is the only indication for the examination)
- Patient able to understand the concept of the study and agreeing to participate
- Patient outside the inclusion age
- All exclusion criteria for a colonoscopy.
- The indication for colonoscopy is not simple screening; for example, assessment of anemia, rectal bleeding, weight loss or abdominal pain.
- Patient's refusal to participate, or patient's inability to understand the study concept
- Any patient with major psychological or psychiatric disorders.
Chirec연구 책임자
Erik Francois, 책임연구자, Principal Investigator, Chirec
연구 대표 연락처
연락처: Erik Francois, M.D., 32 495 77 00 60, [email protected]
연락처: Philippe Langlet, M.D., 32 2 434 8105, [email protected]
1 1개국에 임상시험 장소
Brussels Capital
Hopital Delta Chirec, Auderghem, Brussels Capital, 1160, Belgium
Erik Francois, M.D., 연락처, [email protected]
Erik Francois, M.D., 책임연구자
Philippe Langlet, M.D., 책임연구자