Colorectal Polyp Clinical Decision Support Device Study

Completed

• Conditions: Polyp; Colorectal; Colonoscopy

• Registration Number: NCT04437615
• Lead Sponsor: Olympus Corporation of the Americas

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-11-05
• Primary Completion: 2022-09-18
• Study Completion: 2023-03-30
• Results First Submitted: 2024-03-12
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Results First Posted: 2025-04-17
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2379

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD	Upon receipt of pathology results (within one week)	pathology as ground truth
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.	Upon receipt of pathology results (within one week)	pathology as ground truth
2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.	Upon receipt of pathology results (within one week)	pathology as ground truth
3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.	Upon receipt of pathology results (within one week)	pathology as ground truth
4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.	Upon receipt of pathology results (within one week)	pathology as ground truth
5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.	Upon receipt of pathology results (within one week)	pathology as ground truth

Trial Locations

Locations (1)

Borland Groover; 🇺🇸 Jacksonville, Florida, United States