Computer Aided Polyp Detection (C3PO) Trial

Colonic Polyp Clinical Trial

Official title:

Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777019
• Other study ID #: HSC-MS-20-0687
• Status: Recruiting
• Start date: June 7, 2020
• Est. completion date: June 6, 2025

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Prithvi B Patil, MS
• Phone: 7134801179
• Email: prithvi.b.patil[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Computer aided detection (CADe) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. The aim of this study was to investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes.

Description:

Details regarding polyp size and location, morphology including Paris classification, optical assessment, and bowel preparation were prospectively collected and recorded in the online Redcap software. Final results of polyp histology were also collected. The video library was then independently reviewed for quality assessment by 3 experienced gastroenterologists. Videos that passed the initial quality assessment were then independently evaluated using the Discovery-AI system.

Aim of the study was to evaluate overall performance of Discovery-AI system for polyps of various size, morphology and pathology utilizing a prospectively developed video library.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 6, 2025
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.

• Over 18 years of age

Exclusion Criteria:

• None if they qualify based on inclusion criteria

• Pregnant patients

• Inmate or prisoners

• Unable to provide informed consent

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Other:
• Not applicable as standard of care Colonoscopy
Not applicable since not an intervention

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the accuracy of the novel Pentax Discovery CADe system (Discovery-AI) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls	The video library was developed during screening and surveillance colonoscopy and included details on polyp size, location, morphology, overall Boston bowel preparation score (BBPS) and segmental BBPS. Each video segments ranged from 35 seconds to 75 seconds. Before inclusion, each video was evaluated by 3 expert endoscopists individually to assess overall quality of the video. Quality of video was assessed based on pixel resolution and aspect ratio, bowel preparation, overall speed of withdrawal, colon distension, and adequate mucosal exposure. If the video was deemed of adequate quality by at least 2 endoscopists, it was included in the study cohort.	3 years