Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

NCT ID: NCT06008847

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

674 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-09

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bowel Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lower Gastrointestinal Symptoms

Participant aged over 18 with referred lower gastrointestinal symptoms

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Barcelona

OTHER

Sponsor Role collaborator

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Coventry and Warwickshire

Coventry, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Katie Tompkins

Role: primary

024 7696 27476 ext. 27476

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RA545021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Real Life AI in Polyp Detection
NCT04335318 COMPLETED NA