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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged over 18 years;

• Endoscopically diagnosed with colorectal polyps;

• Signing the written informed consent.

Locations
Other Locations
China
Xijing Hospital of Digestive Disease
RECRUITING
Xi'an
Contact Information
Primary
Zhiguo Liu, M.D
liuzhiguo@fmmu.edu.cn
86-29-84771535
Backup
Jiaqiang Dong, M.D
dongjiaqiang1988@163.com
86-29-84771517
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 450
Treatments
Active_comparator: 2D imaging arm
participants will undergo polypectomy (CSP, CFP, or EMR) using 2D imaging colonoscope
Experimental: 3D imaging arm
participants will undergo polypectomy (CSP, CFP, or EMR) using 3D imaging colonoscope
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov