NCT04437615

Colorectal Polyp Clinical Decision Support Device Study

Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 2,379 (actual)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Polyp
• Colorectal
• Colonoscopy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-05
• Primary completion: 2022-09-18
• Completion: 2023-03-30
• First posted: 2020-06-18
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

1 site across 1 country: United States