Artificial Intelligence (AI) Validation Study for Polyp Detection

Polyp of Colon Clinical Trial

Official title:

Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378660
• Other study ID #: s59405
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: April 18, 2020

Study information

• Verified date: April 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

Description:

This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: April 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• Diagnostic or screening colonoscopy

• Therapeutic colonoscopy

Exclusion Criteria:

• Inability to give informed consent by the patient or legal representative

• < 18 years old

• Any contraindication for colonoscopy or biopsies of the colon

• Uncontrolled coagulopathy

• Confirmed diagnosis of inflammatory bowel disease

• Short bowel or ileostomy

• Pregnancy

Related Conditions & MeSH terms

• Colonic Polyps
• Polyp of Colon
• Polyps

Intervention

Diagnostic Test:
• Artificial intelligence for polyp detection
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Nuovo Regina Margherita Hospital, Rome, Italy, Universitäts Medizin, Mainz, Germany

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard	Determination of the diagnostic accuracy of the novel AI system as second observer	4 months
Secondary	Endoscopist's polyp miss rate as number of extra AI detections	Determination of the AI system's precision and extra value as second observer	4 months