PolypCDSDNCT04437615

Colorectal Polyp Clinical Decision Support Device Study

A study testing Colonoscopy and Clinical Decision Support Device in people with Polyp and Colorectal, run by Olympus Corporation of the Americas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Polyp, Colorectal, Colonoscopy
What is being tested?: Colonoscopy and Clinical Decision Support Device
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,379 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2020to 30 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

≥ 18 years of age
Willing and able to provide informed consent
Subjects undergoing colonoscopy

Who cannot join

Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
Inflammatory Bowel Disease
Hereditary Non Polyposis Colorectal Cancer
Severe coagulopathy
Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
No diminutive polyps detected during colonoscopy

Trial locations and contacts

1 site in 1 country.

United States1 site

Borland Groover
Jacksonville, Florida, 32256

Other trials in United States

About this study

Official title: Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)

The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.

Read the detailed description

Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience.

Consecutive consented patients meeting the entrance criteria will undergo standard colonoscopy with the adjunctive use of CDSD. Sensitivity and specificity of CDSD-unaided and CDSD-aided predictions will be compared with the ground truth of histopathology.

Conditions: Polyp, Colorectal, Colonoscopy
Being tested: Colonoscopy, Clinical Decision Support Device
Keywords: Colon, Polyp, Colorectal, Colonoscopy, AI, Narrow Band Imaging, Polyp Prediction, Artificial Intelligence
Medical subject headings: Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ColonoscopyProcedure or surgery
Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support DeviceDevice
Also called CDSD
The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.

Study groups in NCT04437615
Study group	Role	What they receive
Single-arm	Experimental	CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions. Receives: Procedure: Colonoscopy; Device: Clinical Decision Support Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results.
Measured: Upon receipt of pathology results (within one week)

Secondary outcomes (6)

1. Number of Unaided NBI Prediction and Pathology Result of Diminutive Polyps Detected by the Endoscopist and Confirmed by Pathology for Which CDSD Does Not Return a Prediction.
pathology as ground truth
Measured: Upon receipt of pathology results (within one week)
2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
pathology as ground truth
Measured: Upon receipt of pathology results (within one week)
3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
pathology as ground truth
Measured: Upon receipt of pathology results (within one week)
4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
pathology as ground truth
Measured: Upon receipt of pathology results (within one week)
5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
pathology as ground truth
Measured: Upon receipt of pathology results (within one week)
6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD
pathology as ground truth
Measured: Upon receipt of pathology results (within one week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202030 Mar 2023

First posted18 Jun 2020
Study start5 Nov 2020
Primary completion18 Sep 2022
Study completion30 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Interventional
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: The study shall be a prospective, single arm, multicenter study.
Masking: None (open label)
Enrolment: 2,379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04437615
Sponsor's protocol ID: OCA 2019-GI-03
Acronym: CDSD
Status last verified: Apr 2025
First submitted: 10 Jun 2020
Last updated: 17 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Publications

Rex DK, Bhavsar-Burke I, Buckles D, Burton J, Cartee A, Comar K, Edwards A, Fennimore B, Fischer M, Gerich M, Gilmore A, Hamdeh S, Hoffman J, Ibach M, Jackson M, James-Stevenson T, Kaltenbach T, Kaplan J, Kapur S, Kohm D, Kriss M, Kundumadam S, Kyanam Kabir Baig KR, Menard-Katcher P, Kraft C, Langworthy J, Misra B, Molloy E, Munoz JC, Norvell J, Nowak T, Obaitan I, Patel S, Patel M, Peter S, Reid BM, Rogers N, Ross J, Ryan J, Sagi S, Saito A, Samo S, Sarkis F, Scott FI, Siwiec R, Sullivan S, Wieland A, Zhang J, Repici A, Hassan C, Byrne MF, Rastogi A. Artificial Intelligence for Real-Time Prediction of the Histology of Colorectal Polyps by General Endoscopists. Ann Intern Med. 2024 Jul;177(7):911-918. doi: 10.7326/M24-0086. Epub 2024 May 21.
PubMed 38768450

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
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RecruitingObservational study
A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)
Malignant Colorectal Polyp, Colorectal Cancer
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
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Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
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All Polyp trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)
ClinicalTrials.gov ID: NCT04437615
Acronym / sponsor ID: CDSD / OCA 2019-GI-03
Conditions: Polyp, Colorectal, Colonoscopy
Keywords: Colon, Polyp, Colorectal, Colonoscopy, AI, Narrow Band Imaging, Polyp Prediction, Artificial Intelligence
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,379 participants (actual)
Lead sponsor: Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
Study start: 5 Nov 2020 (actual)
Primary completion: 18 Sep 2022 (actual)
Study completion: 30 Mar 2023 (actual)
First posted: 18 Jun 2020 (actual)
Results: Posted 17 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.

Detailed description

Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study shall be a prospective, single arm, multicenter study.

Arm	Type	Receives
Single-arm	Experimental	Procedure: Colonoscopy, Device: Clinical Decision Support DeviceCDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

≥ 18 years of age
Willing and able to provide informed consent
Subjects undergoing colonoscopy

Key exclusion criteria (6 listed)

Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
Inflammatory Bowel Disease
Hereditary Non Polyposis Colorectal Cancer
Severe coagulopathy
Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.

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
ColonoscopyStandard of care colonoscopy, with added use of CDSD as an adjunctive tool	Procedure or surgery	Single-arm
Clinical Decision Support DeviceAlso: CDSDThe investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.	Device	Single-arm

Primary outcome

Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
Time frame: Upon receipt of pathology results (within one week)
CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results.

6 secondary outcomes

1. Number of Unaided NBI Prediction and Pathology Result of Diminutive Polyps Detected by the Endoscopist and Confirmed by Pathology for Which CDSD Does Not Return a Prediction.
Time frame: Upon receipt of pathology results (within one week)
2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
Time frame: Upon receipt of pathology results (within one week)
3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
Time frame: Upon receipt of pathology results (within one week)
4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
Time frame: Upon receipt of pathology results (within one week)
5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
Time frame: Upon receipt of pathology results (within one week)
6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD
Time frame: Upon receipt of pathology results (within one week)

Results and safety

Results posted to the registry on 17 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-arm	2,379	1,290

Primary outcome: Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology

Time frame: Upon receipt of pathology results (within one week). Number (95% Confidence Interval). Unit: percentage of polyps

Measure	CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp n = 1252
Sensitivity for CDSD aided	90.8 (89.3 to 92.3)
Sensitivity for CDSD unaided	90.7 (89.2 to 92.2)
specificity for CDSD aided	64.7 (61.7 to 67.8)
specificity for CDSD unaided	59.5 (56.6 to 62.7)

Population analysed: Total number of polyps from eligible participants (N=1252) who completed the study and had a successful CDSD prediction.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-arm	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38768450Rex DK, Bhavsar-Burke I, Buckles D, Burton J, Cartee A, Comar K, Edwards A, Fennimore B, Fischer M, Gerich M, Gilmore A, Hamdeh S, Hoffman J, Ibach M, Jackson M, James-Stevenson T, Kaltenbach T, Kaplan J, Kapur S, Kohm D, Kriss M, Kundumadam S, Kyanam Kabir Baig KR, Menard-Katcher P, Kraft C, Langworthy J, Misra B, Molloy E, Munoz JC, Norvell J, Nowak T, Obaitan I, Patel S, Patel M, Peter S, Reid BM, Rogers N, Ross J, Ryan J, Sagi S, Saito A, Samo S, Sarkis F, Scott FI, Siwiec R, Sullivan S, Wieland A, Zhang J, Repici A, Hassan C, Byrne MF, Rastogi A. Artificial Intelligence for Real-Time Prediction of the Histology of Colorectal Polyps by General Endoscopists. Ann Intern Med. 2024 Jul;177(7):911-918. doi: 10.7326/M24-0086. Epub 2024 May 21.
Individual participant dataSharing planned: Yes

Related trials for Polyp

RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
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RecruitingObservational study
A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)
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A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Colonoscopy and Clinical Decision Support Device in people with Polyp and Colorectal, run by Olympus Corporation of the Americas at 1 site in United States.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology (time frame: Upon receipt of pathology results (within one week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04437615, which also lists 1 linked publication.

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 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.