Colorectal Polyp Clinical Decision Support Device Study (CDSD)

Olympus

Status: Completed

Conditions: Colorectal; Colonoscopy; Polyp

Treatments: Procedure: Colonoscopy; Device: Clinical Decision Support Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04437615

OCA 2019-GI-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,379 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2,379 participants in 1 patient group

Single-arm

Experimental group

Description:

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.

Treatment:

Device: Clinical Decision Support Device

Procedure: Colonoscopy