Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 241
- 试验地点
- 3
- 主要终点
- SCALE-EYE diagnostic performance versus biopsy-forceps
研究概览
简要总结
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.
详细描述
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 than the participants, approximately 289 colorectal polyps are planned to be included. Based on an expected detection rate of roughly 1.20 polyps per colonoscopy in the study population, approximately 241 participants aged 55-80 years old, who are referred for screening or surveillance colonoscopy at the participating study sites and have signed the informed consent form (ICF), will be included into the study. Polyps of all shapes (flat, sessile, pedunculated) that are found during colonoscopy and are smaller than 25 mm, as judged by the endoscopist using optical assessment, are considered eligible for inclusion.
Intervention: Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist and then in a randomized order measured by biopsy-forceps assisted measurement and SCALE-EYE measurement.
Primary outcome measurement: 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SCALE-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.
干预措施: SCALE-EYE (1) (Device)
Biopsy-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.
干预措施: SCALE-EYE (2) (Device)
结局指标
主要结局
SCALE-EYE diagnostic performance versus biopsy-forceps
时间窗: Immediately after the screening and/or surveillance colonoscopy
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.
次要结局
- (Serious) adverse events(Up to 30 days post-colonoscopy)
- Surveillance interval agreement(After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy))
- SCALE-EYE diagnostic performance versus optical assessment(Immediately after the screening and/or surveillance colonoscopy)
- Sustainability(After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy))
- Learning curve(Immediately after the screening and/or surveillance colonoscopy)
研究者
Peter Siersema
Prof. Dr. P.D. Siersema
Erasmus Medical Center