Colorectal Polyp Clinical Decision Support Device Study (CDSD)

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Colorectal; Polyp
• Intervention / Treatment: Procedure: Colonoscopy; Device: Clinical Decision Support Device

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.

• Study Type: Interventional
• Enrollment (Actual): 2379

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Borland Groover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm; 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; Standard of care colonoscopy, with added use of CDSD as an adjunctive tool; Device: Clinical Decision Support Device; The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.; Other Names: CDSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Upon receipt of pathology results (within one week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Upon receipt of pathology results (within one week)
4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.	pathology as ground truth	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	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	Upon receipt of pathology results (within one week)

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): September 18, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Colonoscopy; Artificial Intelligence; AI; Colon; Colorectal; Polyp; Narrow Band Imaging; Polyp Prediction
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: OCA 2019-GI-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Immediately - 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL