Colorectal Polyp Clinical Decision Support Device Study

Olympus Corporation of the Americas2,379 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

2,379

Conditions

Polyp Colorectal Colonoscopy

Interventions

ColonoscopyPROCEDURE

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

Clinical Decision Support DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Borland Groover

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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.