임상 레이더 AI | ||
|---|---|---|
임상시험 NCT06251700 (ENDOAID-PRO)은(는) Screening Colonscopy에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence (ENDOAID-PRO) 775
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
- ENDOAID-PRO
- 2023.541
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Intervention arm CADe system will be used during withdrawal phase of colonscopy | ENDO-AID CADe ENDO-AID CADe will be used during the withdrawal process of the colonscopy |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Post-colonoscopy adenomas at year 3 | The primary endpoint is the incidence of post-colonoscopy adenomas at year 3, which is the composite of new occurrence and metachronous recurrence of adenomas during surveillance. | During the colonoscopy |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Post-colonoscopy AA | Incidence of post-colonoscopy advanced adenomas | During the colonoscopy |
Post-colonoscopy advanced neoplasms | Incidence of post-colonoscopy advanced neoplasms | During the colonoscopy |
Post-colonoscopy SSL | Incidence of post-colonoscopy SSL | During the colonoscopy |
Post-colonoscopy CRC | Incidence of post-colonoscopy CRC | During the colonoscopy |
Post-colonoscopy adenomas and advanced adenomas | Number of post-colonoscopy adenomas and advanced adenomas | During the colonoscopy |
Size and location of post-colonoscopy adenomas and advanced adenomas | Size and location of post-colonoscopy adenomas and advanced adenomas | During the colonoscopy |
High-risk and low-risk group according to USMSTF guideline | Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline | During the colonoscopy |
Subjects are eligible if:
(i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study \[NCT04838951\]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.
(i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.