Clinical Trial

Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy

Completed
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to correctly classify colon polyps and adenomas during colonoscopy to guide the selection of proper treatment procedures. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are: Does 3-dimensional (3D) imaging device improve the correct classification as well as size and depth evaluation of polyps and adenomas during colonoscopy using pathology as gold standard? What adverse events do participants experience during colonoscopy and polypectomy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve classification and evaluation accuracy. Participants will: Undertake colonoscopy examination and polypectomy using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-03; most recent amendment 2026-03-16.
Status change: Recruiting → Completed 2026-03-10
Status change: Not Yet Recruiting → Recruiting 2025-04-21
Trial Details
NCT Number NCT06922877
Lead Sponsor Xijing Hospital of Digestive Diseases
Conditions Colorectal Polyps, Colorectal Adenomas
Enrollment 460 participants
Start Date 2023-10-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-19