NCT07308743

Brief Summary

This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
686

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Jul 2027

Study Start

First participant enrolled

December 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Colon PolypsSessile Serrated LesionColon Adenomas

Keywords

computer-aided detectionproximal adenoma miss rateRandomized Tandem Colonoscopy Study

Outcome Measures

Primary Outcomes (1)

  • Proximal adenoma missed rate

    The number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection.

    One day

Secondary Outcomes (3)

  • Proximal polyp missed rate

    One day

  • Proximal SSLs missed rate

    One days

  • Proximal advanced adenoma missed rate

    One day

Study Arms (2)

Computer-aided detection-assisted colonoscopy

EXPERIMENTAL

Tandem colonoscopy of proximal colon assisted with computer-aided detection system followed by conventional white-light colonoscopy

Device: Computer-aided detection-assisted colonoscopy

Conventional white-light colonoscopy

ACTIVE COMPARATOR

Tandem conventional white-light colonoscopy of proximal colon followed by usual computer-aided detection-assisted colonoscopy

Procedure: Conventional white-light colonoscopy

Interventions

Computer-aided detection-assisted colonoscopyDEVICE

Computer-aided detection-assisted colonoscopy for detection of colonic polyp

Computer-aided detection-assisted colonoscopy
Conventional white-light colonoscopyPROCEDURE

Conventional white-light colonoscopy

Conventional white-light colonoscopy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age 40-75 years old, regardless of gender
  • Patients presenting for physical examination, colorectal cancer screening or diagnosis
  • Patients voluntarily signs an informed consent form

You may not qualify if:

  • Unable to cooperate ot tolerate colonoscopy
  • History of inflammatory bowel disease
  • History of colorectal cancer
  • Previous colorectal surgery
  • History of recurrent constipation
  • Taking anticoagulant and antiplatelet drugs berfore procedure
  • High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
  • Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Zelong Han, MD, PhD

CONTACT

+86 189-2506-1890hanzelong2025@163.com

Bitao Lin, MD

CONTACT

+86 137-2532-1385linbitao1996@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Prospective randomized design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 30, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

CN(1)