CompletedNot Applicable

Colorectal Polyp Clinical Decision Support Device Study

United States2,379 participantsStarted 2020-11-05

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology

Timeframe: Upon receipt of pathology results (within one week)

Trial details

NCT IDNCT04437615

SponsorOlympus Corporation of the Americas

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-18

Results submitted2024-03-12

View on ClinicalTrials.gov More Polyp trials