Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

Summary

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. 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 identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? 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 high risk adenoma identification.

Participants will:

Undertake colonoscopy examination 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 Adenoma
• Colorectal Polyps

Interventions

PROCEDURE

Colonoscopy after bowel cleansing with 2D imaging device

participants will undergo colonoscopy examination using 2D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.

PROCEDURE

Colonoscopy after bowel cleansing with 3D imaging device

participants will undergo colonoscopy examination using 3D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.

Sponsors & Collaborators

• Beijing Friendship Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Xijing Hospital of Digestive Diseases

  lead OTHER

Principal Investigators

• Zhiguo Liu, M.D · Xijing Hospital of Digestive Disease

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2026-06-01

Completion

2026-07-01