NCT05064124Recruiting
Early DiAgnosis Real-Time Healthcare System for CANcer Trial
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of the study is to assess whether the AI characterisation system of the CADDIE device improves the endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps in the bowel during colonoscopy. Participants will either have a colonoscopy with the assistance of the CADDIE device characterisation AI system ("intervention group") or have a colonoscopy in line with routine clinical practice i.e., without the CADDIE device characterisation AI system ("control group"). The randomisation method of this trial will allocate enrolled participants to the "intervention" group and to the "control" group by a technique similar to flipping a coin.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 420 (estimated)
- First submitted
- 8 Sept 2021
- Start date
- 18 Jul 2024
- Primary completion date
- 31 May 2025
- Lead sponsor
- University College, London
- NCT number
- NCT05064124
What you commit to
- Study type: Observational
- Planned participants: 420
- From 18 Jul 2024 to the primary completion date, 31 May 2025
- 1 site in 1 country
- 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.
Other illness
- Participants with inflammatory bowel disease (IBD)
- Participants with current Colorectal Cancer (CRC)
- Participant is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding
Lab values
- Participants with a contraindication for biopsy or polypectomy. These include:
- Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines.
- Participants with a history of haemostasis disorders (haemostasis disorders will include but will not be limited to: participants with haemophilia or other congenitally acquired clotting factor deficiencies, participants with cirrhosis with coagulopathy, participants known to have thrombocytopenia (\<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders)
Other
- Emergency and/or inpatient colonoscopies
Who the study is looking for
- Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.
- Male and female participants aged 18 years or older at the time of informed consent.
- Participants able to comprehend, sign and date the written informed consent document to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.