임상 레이더 AI | ||
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임상시험 NCT07005453 (ASSEMBLE)은(는) Colorectal Polyps에 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
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size (ASSEMBLE) 241 무작위 배정
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 NCT07005453 (ASSEMBLE)은(는) Colorectal Polyps에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 9월 23일에 시작되어 241명의 참여자를 모집하고 있습니다. Erasmus Medical Center이(가) 진행하며, 2026년 4월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 13일에 갱신되었습니다.
간단한 개요
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.
Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.
상세한 설명
Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated.
Study design: A multicenter, randomized, parallel group, endoscopist blinded study.
Study population: The unit of analysis is the colorectal polyp rather t...
더 보기공식 제목
Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
질환명
Colorectal Polyps기타 연구 식별자
- ASSEMBLE
- MEC-2024-0789
NCT 번호
실제 연구 시작일
2025-09-23
최신 업데이트 게시
2026-01-13
예상 연구 완료일
2026-04-01
계획된 등록 인원
241
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
virtual scale endoscopy
biopsy forceps
optical assessment
colorectal cancer
biopsy forceps
optical assessment
colorectal cancer
주요 목적
진단
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
기타SCALE-EYE measurement than biopsy-forceps assisted measurement When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by SCALE-EYE measurement and afterwards by biopsy-forceps assisted measurement. | SCALE-EYE (1) Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement. |
기타Biopsy-forceps assisted measurement than SCALE-EYE measurement When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by biopsy-forceps assisted measurement and afterwards by SCALE-EYE measurement. | SCALE-EYE (2) Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
SCALE-EYE diagnostic performance versus biopsy-forceps | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard. | Immediately after the screening and/or surveillance colonoscopy |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
SCALE-EYE diagnostic performance versus optical assessment | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment for polyp size measurement. This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to optical assessment. | Immediately after the screening and/or surveillance colonoscopy |
Sustainability | The sustainability aspect of SCALE-EYE will be assessed by exploring whether the number of colonoscopies, the colonoscopy-associated waste and carbon footprint will be reduced by correct size measurement. | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) |
Learning curve | The learning curve will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty. | Immediately after the screening and/or surveillance colonoscopy |
Surveillance interval agreement | The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard (biopsy-forceps assisted measurement) will be compared. | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) |
(Serious) adverse events | Serious adverse events (SAEs) and adverse events (AEs) will be summarized by proportions. | Up to 30 days post-colonoscopy |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
55 Years
참여 가능한 성별
전체
- Participants aged 55-80
- Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy
- Polyps of all forms ≤25 mm as assessed by the endoscopist
- No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present
- Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) <2 per segment)
- Intraprocedural complications, not caused by the study device
- Known or suspected inflammatory bowel disease (IBD)
- Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)
- Ileoanal pouch and anastomosis
- History of radiation or chemotherapy for colorectal lesions
- Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD))
- Pregnancy
- No Informed consent (IC) possible
Erasmus Medical Center연구 책임자
Peter Siersema, 책임연구자, Prof. Dr. P.D. Siersema, Erasmus Medical Center
연락처 정보가 없습니다.
3 1개국에 임상시험 장소
North Brabant
Catharina Ziekenhuis, Eindhoven, North Brabant, 5623 EJ, Netherlands
Ramon-Michel Schreuder, Dr., 연락처, +31 40 2399750, [email protected]
모집중
South Holland
LUMC, Leiden, South Holland, 2333 ZG, Netherlands
Jurjen Boonstra, Dr., 연락처, +31 71 5263575, [email protected]
모집중
Erasmus MC, Rotterdam, South Holland, 3015 GD, Netherlands
Demi Gerritsen, MSc, 연락처, +31 650033985, [email protected]
모집중