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Computer Aided Polyp Detection (C3PO) Trial

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ClinicalTrials.gov Identifier: NCT04777019
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Nirav C Thosani, The University of Texas Health Science Center, Houston

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Colonic Polyp Other: Not applicable as standard of care Colonoscopy

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps
Actual Study Start Date : June 7, 2020
Estimated Primary Completion Date : June 7, 2023
Estimated Study Completion Date : June 6, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Not applicable as standard of care Colonoscopy
    Not applicable since not an intervention

Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Currently, the most commonly used quality marker in conventional colonoscopy (CC) is adenoma detection rate (ADR), which has been shown to inversely correlate with the incidence of CRC.3 Although colonoscopy is generally considered to be the most accurate screening modality, a substantial number of polyps are still missed. Hence population scheduled for a colonoscopy at either of the institution were part of the project.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777019


Contacts
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Contact: Prithvi B Patil, MS 7134801179 prithvi.b.patil@uth.tmc.edu
Contact: Nirav Thosani, MD, MHA 7135006677 nirav.thosani@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Prithvi B Patil    713-480-1179    prithvi.b.patil@uth.tmc.edu   
Contact: Prithvi Patil, MS    7135006456    prithvi.b.patil@uth.tmc.edu   
Principal Investigator: Nirav Thosani, MD,MHA         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Nirav C Thosani, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04777019    
Other Study ID Numbers: HSC-MS-20-0687
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps