Colonic PolypNCT04777019
Computer Aided Polyp Detection (C3PO) Trial
An observational study of Colonic Polyp, run by The University of Texas Health Science Center, Houston.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2020to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.
- Over 18 years of age
Who cannot join
- None if they qualify based on inclusion criteria
- Pregnant patients
- Inmate or prisoners
- Unable to provide informed consent
About this study
Official title: Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps
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.
Read the 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.
- Conditions
- Colonic Polyp
- Being tested
- Not applicable as standard of care Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable as standard of care ColonoscopyOther
Not applicable since not an intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start7 Jun 2020
- Primary completion7 Jun 2023 (estimated)
- Study completion6 Jun 2025 (estimated)
Why it stopped: Study device not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav C Thosani, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777019
- Sponsor's protocol ID
- HSC-MS-20-0687
- Status last verified
- Aug 2025
- First submitted
- 2 Feb 2021
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Aided Polyp Detection (C3PO) Trial: A Multicenter International Trial Evaluating Diagnostic Accuracy of Artificial Intelligence System in Detecting Colon Polyps
- ClinicalTrials.gov ID
- NCT04777019
- Acronym / sponsor ID
- HSC-MS-20-0687
- Conditions
- Colonic Polyp
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study device not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 7 Jun 2023 (estimated)
- Study completion
- 6 Jun 2025 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients scheduled for a regular or screening colonoscopy at the institution as standard of care.
- Over 18 years of age
Key exclusion criteria (4 listed)
- None if they qualify based on inclusion criteria
- Pregnant patients
- Inmate or prisoners
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable as standard of care ColonoscopyNot applicable since not an intervention | Other | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.