Colorectal Polyp Clinical Decision Support Device Study

NCT04437615 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 2379

Last updated 2025-04-17

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2022-09-18
Completion
2023-03-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437615 on ClinicalTrials.gov