Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

NCT05870332 | Recruiting DMC FDA Device

• 1 other identifier: 292323
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to determine whether use of a Computer Assisted Detection (CADe) programme leads to an increase in ADR for either units or individual colonoscopists, independent of setting or expertise

Conditions

Colonic Polyp; Colonic Adenoma; Colo-rectal Cancer

Keywords

Artificial Intelligence; Computer assisted detection (CADe); Colorectal cancer; Adenoma Detection Rate (ADR)

Outcome Measures

Primary Outcomes (1)

• CADe-ADR in real world practice

  The primary outcome measure will be adenoma detection rate. This will be studied across three phases: prior to use of CADe (baseline practice), while using CADe (study period) and finally after CADe (without the device in situ: "washout" phase).

  24 months

Secondary Outcomes (3)

• APC

  24 months

• Polyp characteristics

  24 months

• Procedure time

  24 months

Study Arms (1)

All patients

Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy

Device: GI Genius (GIG)

Interventions

GI Genius (GIG) DEVICE

GIG is an artificial intelligence unit that assists human colonoscopist in real-time to detect polyps during colonoscopy. Four months collection period prior to activating GIG, then four months with GIG, and Four months afterwards without GIG

Also known as: CADe

All patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unselected patients scheduled for diagnostic colonoscopy

You may qualify if:

• Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria

You may not qualify if:

• Colonoscopy being performed for polyp surveillance
• Unable to provide informed, written consent

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Medtronic: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Prof Bu'Hussain B Hayee

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Bu'Hussain B Hayee, PHD FRCP

CONTACT

02032996044; b.hayee@nhs.net

Dr Olaolu Olabintan, MBBS MRCP

CONTACT

07939056819; olaolu.olabintan@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 23, 2023
• Study Start: October 16, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 31, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

GB (1)