- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06008847
Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study (CESCAIL)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Coventry
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Coventry, Coventry, United Kingdom, CV2 2DX
- University Hospitals Coventry and Warwickshire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Lower Gastrointestinal Symptoms
Participant aged over 18 with referred lower gastrointestinal symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity and specificity of polyp detection in AI enabled CCE reporting
Time Frame: 11 months
|
Sensitivity and specificity of polyp detection in AI enabled CCE reporting
|
11 months
|
|
Time taken to read video by clinicians and AI tool
Time Frame: 11 months
|
Time taken to read video by clinicians and AI tool
|
11 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA545021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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