Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

NCT ID: NCT06924489

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1566 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-07-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

2D imaging arm

participants will undergo colonoscopy examination using 2D imaging colonoscope

Group Type: ACTIVE_COMPARATOR

Colonoscopy after bowel cleansing with 2D imaging device

Intervention Type: PROCEDURE

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.

3D imaging arm

participants will undergo colonoscopy examination using 3D imaging colonoscope

Group Type: EXPERIMENTAL

Colonoscopy after bowel cleansing with 3D imaging device

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Aged 18-75 years;
• Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
• Signing the written informed consent;

Exclusion Criteria

• Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis [FAP], Lynch syndrome, etc.);
• Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
• Patients with a history of colorectal adenocarcinoma or alarming symptoms;
• Patients with a history of inflammatory bowel disease;
• Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
• Patients with severe cardiopulmonary insufficiency;
• Patients with severe coagulation disorders or high bleeding risk (platelets <50×10⁹/L, INR >1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
• Patients with severe electrolyte imbalances;
• Patients with acute peritonitis or suspected intestinal perforation;
• Patients with toxic megacolon;
• Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
• Patients with untreated severe abdominal hernia, intestinal obstruction;
• Patients with intestinal strictures of any cause;
• Pregnancy and lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Liu

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiguo Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Disease

Central Contacts

zhiguo Liu, M.D

Role: CONTACT

liuzhiguo@fmmu.edu.cn

86-29-84771535

Jiaqiang Dong, M.D

Role: CONTACT

dongjiaqiang1988@163.com

Other Identifiers

KY20242132-F-1

Identifier Type: -

Identifier Source: org_study_id