NCT06922877

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

Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy: a Single-center Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Polyps
• Colorectal Adenomas

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope	endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope
DIAGNOSTIC_TEST	endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope	endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2025-04-11
• Last updated: 2026-03-19

Locations

1 site across 1 country: China