Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

Bowel Cancer Clinical Trial

— CESCAIL  

Official title:

Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008847
• Other study ID #: RA545021
• Status: Recruiting
• Start date: February 9, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a minimally-invasive imaging device, to improve efficiency and accuracy of the detection of polyps, which are little outgrowths within the lining of the bowel.

Description:

Participants will be continuing to follow their standard care pathway, and there are no additional requirements of the participants other than providing consent for their pseudonymised capsule video and data to be used to test the AI system.

The participant's final diagnosis will only be determined by the clinician's standard analysis pathway and not influenced by the AI enabled analysis pathway. All data is de-identified before a video is created and re-identified only once the standard final report is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed data is minimised.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 674
• Est. completion date: January 31, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or over

• Patients who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care

Exclusion Criteria:

• Patients unable to provide consent to take part in the study

Related Conditions & MeSH terms

• Bowel Cancer

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry and Warwickshire	Coventry

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	University of Barcelona

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of polyp detection in AI enabled CCE reporting	Sensitivity and specificity of polyp detection in AI enabled CCE reporting	11 months
Primary	Time taken to read video by clinicians and AI tool	Time taken to read video by clinicians and AI tool	11 months