NCT05611151Completed
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC). Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy : * Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group) * Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 830 (actual)
- First submitted
- 1 Nov 2022
- Start date
- 30 Apr 2023
- Primary completion date
- 10 Sept 2024
- Lead sponsor
- NEC Corporation
- Diseases
- Colorectal cancer
- NCT number
- NCT05611151
What you commit to
- Study type: Interventional
- Participants enrolled: 830
- From 30 Apr 2023 to the primary completion date, 10 Sept 2024
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Colonoscopy within the previous three (3) years
- Antithrombotic therapy that cannot be stopped, precluding polyp resection
- Referred for endoscopic mucosal resection (EMR)
Other illness
- Inflammatory bowel disease
- Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome
Other
- Contraindications to colonoscopy
- High-risk indications for colonoscopy
- Pregnant or planning a pregnancy during the study period
Who the study is looking for
- Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
- Signed Informed Consent
Age in the registry: 45 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GastroZentrum Lippe Coordinator of this site? Confirm its status | Bad Salzuflen | Germany | Unknown status |
| Portsmouth Hospitals University NHS Trust, Cosham Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Unknown status |
| Humanitas Mater Domini Coordinator of this site? Confirm its status | Castellanza | Italy | Unknown status |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Kansas City VA Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.