임상 레이더 AI | ||
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임상시험 NCT05244278은(는) 인공지능에 대해 모집중 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 (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies 1,596 무작위 배정 이중 눈가림
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 NCT05244278은(는) 인공지능에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2023년 8월 1일에 시작되어 1,596명의 참여자를 모집하고 있습니다. Centre hospitalier de l'Université de Montréal (CHUM)이(가) 진행하며, 2027년 1월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 3월 5일에 갱신되었습니다.
간단한 개요
This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.
상세한 설명
This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).
Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms...
더 보기공식 제목
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
질환명
인공지능기타 연구 식별자
- 2022-10312, 21.297
NCT 번호
실제 연구 시작일
2023-08-01
최신 업데이트 게시
2025-03-05
예상 연구 완료일
2027-01-01
계획된 등록 인원
1,596
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Polyp detection
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
주요 목적
진단
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Operating room equipped with the CADe (Medtronic-GI genius for real-time detection) The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. | Medtronic-GI genius (CADe system for detecting colorectal polyps) Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. |
비개입Colonoscopy performed in room without CADe system In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
ADR | The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected. | 30 days |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean number of adenomas per colonoscopy (APC) | Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed | 30 days |
Sessile serrated lesions (SSL) detection rate | Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified | 30 days |
Sessile serrated lesion per Colonoscopy (SSLPC) | Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies | 30 days |
Advanced lesion detection rate (ALDR) | Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma \>10mm was at least 1. | 30 days |
Proximal ADR | Proximal ADR is defined as the prevalence of patients with at least 1 adenoma detected proximal to the splenic flexure | 30 days |
Proportion neoplastic and non-neoplastic polyps | Proportion neoplastic and non-neoplastic polyps (i.e., SSLs, hyperplastic polyps, and high-grade dysplasia and carcinomas (overall and according to size, location, and morphology) | 30 days |
CADe utilization rate | CADe utilization rate (when available in the room). Since the CADe utilization rate cannot be assessed without revealing the ongoing trial to the endoscopists, two voluntary self-reported measures and a partially objective measure. First, endoscopists will be surveyed via email during and at the end of the trial regarding their use of CADe, while keeping them unaware of the ongoing trial. Second, the proportion with endoscopy reports for which is is explicitly stated that CADe was used will be computed. | Through study completion, an average of 3 years |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
45 Years
참여 가능한 성별
전체
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-89 years
- Patients undergoing emergency colonoscopy
- Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
Centre hospitalier de l'Université de Montréal (CHUM)연구 책임자
Daniel Von Renteln, 책임연구자, Gastroenterologist, Principal Scientist, MD, PhD, Centre hospitalier de l'Université de Montréal (CHUM)
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Quebec
Centre Hospitalier Universitaire de Montréal, Montreal, Quebec, Canada
Samira Hanin, 연락처, 514-890-8000, [email protected]
Daniel von Renteln, MD, PhD, 책임연구자
모집중