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Completed

NCT Number: NCT04437615

Colorectal Polyp Clinical Decision Support Device Study

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

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Key information

Conditions

Polyp Colonoscopy Colorectal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Borland Groover

Jacksonville, Florida, 32256, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

colonoscopy

Procedure

Standard of care colonoscopy, with added use of CDSD as an adjunctive tool

Clinical Decision Support Device

Device

The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.

Other names: CDSD

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    pathology as ground truth

  2. 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)

    pathology as ground truth

  3. 3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.

    Time frame: Upon receipt of pathology results (within one week)

    pathology as ground truth

  4. 4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.

    Time frame: Upon receipt of pathology results (within one week)

    pathology as ground truth

  5. 5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.

    Time frame: Upon receipt of pathology results (within one week)

    pathology as ground truth

  6. 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)

    pathology as ground truth

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Registry information

Official study title

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

Acronym: CDSD

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 18, 2020
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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