Colorectal Polyp Clinical Decision Support Device Study

NCT04437615 | Completed Results

• 1 other identifier: OCA 2019-GI-03
• Study Type: interventional
• Target: 2,379
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polyp; Colorectal; Colonoscopy

Keywords

Colon; Polyp; Colorectal; Colonoscopy; AI; Narrow Band Imaging; Polyp Prediction; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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 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.

  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.

  Upon receipt of pathology results (within one week)

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

  Upon receipt of pathology results (within one week)

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

  Upon receipt of pathology results (within one week)

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

  Upon receipt of pathology results (within one week)

Study Arms (1)

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.

Procedure: Colonoscopy; Device: Clinical Decision Support Device

Interventions

Colonoscopy PROCEDURE

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

Single-arm

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.

Also known as: CDSD

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead

Study Sites (1)

Borland Groover

Jacksonville, Florida, 32256, United States

Location

Related Publications (1)

• 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.

  PMID: 38768450 DERIVED

MeSH Terms

Conditions

Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Jeremy Bolt, Global GI Lead
• Organization: Olympus Corporation

jeremy.bolt@olympus.com

5085798495

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Masking Details: The pathologist (outcomes assessor) is blinded to the endoscopist predictions and CDSD prediction.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study shall be a prospective, single arm, multicenter study.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 18, 2020
• Study Start: November 5, 2020
• Primary Completion: September 18, 2022
• Study Completion: March 30, 2023
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately - 3 years

Locations

US (1)