An interventional study of Colonoscopy and Clinical Decision Support Device in Polyp, Colorectal and Colonoscopy, sponsored by Olympus Corporation of the Americas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Olympus Corporation of the Americas (part of Olympus Corporation) · Interventional and Other
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
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.
312 studies on the registry are indexed under Polyps; 60 are open to participants now.
This study's enrollment of 2,379 is above the median of 150 across 204 interventional studies indexed under Polyps.
Browse Polyps studies →Olympus Corporation of the Americas is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Colonoscopy · Device: Clinical Decision Support Device
Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
Also known as: CDSD
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.
Time frame: Upon receipt of pathology results (within one week)
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
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.
pathology as ground truth
Time frame: 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
Time frame: Upon receipt of pathology results (within one week)
4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
pathology as ground truth
Time frame: 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
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
pathology as ground truth
Time frame: Upon receipt of pathology results (within one week)
| Milestone | Single-arm |
|---|---|
| Started | 2379 |
| Completed | 1290 |
| Not completed | 1089 |
| Withdrew: Screen fails/withdrawal | 1089 |
CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results.
| percentage of polyps | CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp |
|---|---|
| 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) |
pathology as ground truth
| number of polyps without CDSD prediction | All Patients Who Completed the Study |
|---|---|
| 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. | 112 |
pathology as ground truth
| percentage of polyps | Unaided WLE Prediction Compared With Pathology |
|---|---|
| Sensitivity | 88.5 |
| Specificity | 61.1 |
| Negative predictive value (NPV) | 74.7 |
| Positive predictive value (PPV) | 80.4 |
pathology as ground truth
| percentage of polyps | Unaided NBI Prediction Compared With Pathology |
|---|---|
| Sensitivity | 90.7 |
| Specificity | 59.5 |
| PPV | 74.6 |
| NPV | 83.8 |
pathology as ground truth
| percentage of polyps | CDSD Prediction Compared With Pathology |
|---|---|
| Sensitivity | 86.5 |
| Specificity | 69.5 |
| PPV | 78.6 |
| NPV | 79.9 |
pathology as ground truth
| percentage of polyps | CDSD-Aided Prediction Compared With Pathology |
|---|---|
| Sensitivity | 90.8 |
| Specificity | 64.7 |
| PPV | 76.8 |
| NPV | 85.0 |
pathology as ground truth
| Polyps | Unaided Predictions Using NBI and Aided Predictions With CDSD Pathology |
|---|---|
| 6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD | 251 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single-arm | — | — | — |
Eligible patients that rec'd a colonoscope and a successful CDSD prediction.
| Age, Categorical(Participants) | Single-arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 763 |
| >=65 years | 489 |
| Age, Continuous(years) | Single-arm |
|---|---|
| Mean | 60.6 ± 10.8 |
| Sex: Female, Male(Participants) | Single-arm |
|---|---|
| Female | 601 |
| Male | 651 |
| Race/Ethnicity, Customized(Participants) | Single-arm |
|---|---|
| Caucasian | 976 |
| Asian | 19 |
| African American | 180 |
| Hispanic | 52 |
| Native American | 4 |
| Pacific Islander | 0 |
| Middle Eastern | 5 |
| Other | 16 |
| Region of Enrollment(Participants) | Single-arm |
|---|---|
| United States | 1252 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol
Time frame: Immediately - 3 years
Ran from Nov 2020 to primary completion in Sep 2022, 22 months.
Results were first posted in Apr 2025, 2 years 6 months after primary completion.
Of 79 interventional studies with no phase under Polyps, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 22 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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