AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- Docbot, Inc.
- 入组人数
- 978
- 试验地点
- 9
- 主要终点
- Overall adenomas per extraction, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard hiigh definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
研究概览
简要总结
The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Triple (Participant, Pathologist, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary Inclusion Criteria.
- •Average risk asymptomatic subjects undergoing a first colonoscopy (screening) or screening colonoscopy at least 10 years after prior colonoscopy.
- •Aged 45 years to aged 75 years at the time of enrollment.
- •Capable of providing written informed consent and willing and able to adhere to all protocol requirements, and/or the subject's legally acceptable representative(s) capable of providing written informed consent.
排除标准
- •History of any colorectal cancer or colon adenomas.
- •History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis.
- •Family history of colon cancer or precancerous colon polyp in a first degree relative before age
- •Polyposis syndromes including Familial Adenomatous Polyposis, Cowden syndrome, Lynch syndrome, Peutz-Jeghers syndrome, MUTYH Associated Polyposis, Familial Colorectal Cancer Type X.
- •Surveillance, therapeutic, preoperative, or diagnostic colonoscopy.
- •Colonoscopy for work-up of abdominal or pelvic symptoms including abdominal pain, flank pain, pelvic pain, subject report of altered stool, subject report of anemia within the past 12 months, subject report of gastrointestinal bleeding including bright red blood per rectum or tarry stools, constipation, diarrhea, subject reported history of abdominal or pelvic mass, subject report of unintentional weight loss.
- •Workup or referral to diagnose or evaluate abnormal imaging of the abdomen or pelvis.
- •Positive Fecal Immunochemical Test history.
- •Severe co-mobordity, including end-stage cardiovascular, pulmonary, liver, or renal disease.
- •History of colon resection, not including the appendix.
- •Currently receiving a therapy not permitted during the trial, as defined in Section 8.
- •Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the trial.
- •Enrolled subjects will be eligible for Post-procedure Periods if their colonoscopy meets the following criteria:
- •Adequate bowel preparation score per the Boston Bowel Preparation Scoring System (BBPS) > or equal to 2 in all colonic segments.
- •Colonoscopies with successful cecal intubation.
- •Colonoscopies with withdrawal times of at least 6 minutes.
研究组 & 干预措施
Ultivision AI Software enhanced screening colonoscopy
Ultivision Artificial Intelligence enhanced screening colonoscopies will be performed.
干预措施: Ultivision Artificial Intelligence Software (Device)
No AI enhancement screening colonoscopy
Screening colonoscopies without Artificial Intelligence enhancement will be performed.
干预措施: No Artificial Intelligence Software enhancement (Device)
结局指标
主要结局
Overall adenomas per extraction, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard hiigh definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
时间窗: through study completion, an average of 1 year
The primary safety endpoint is the adenomas per extraction per colonoscopy procedure (APE), as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus SHDWLC without AI.
Overall adenoma detection, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
时间窗: through study completion, an average of 1 year
The primary efficacy endpoint is the mean adenomas per colonoscopy procedure (MAP) detection, as defined by the protocol, with Ultivision AI software enhancement to screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.
次要结局
- Adenoma detection rate, as defined by the protocol, using Ultivision AI software in subjects undergoing screening standard high definition white light colonoscopy (SHDWLC) versus screening SHDWLC without AI.(through study completion, an average of 1 year)