NCT06979232

Brief Summary

  1. 1.Study on Adenoma Detection Rate (ADR) Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI);
  2. 2.Study Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI) for Detection Rates of Sessile Serrated Lesions (SSLs), Total Polyp Detection Rate, and Advanced Adenoma Detection Rate;
  3. 3.Study on Polyp Characteristics (Size, Location, etc.) Observed Using Conventional White Light Endoscopy (WLI) and Enhanced White Light Endoscopy (E-WLI).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025May 2026

First Submitted

Initial submission to the registry

May 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

May 11, 2025

Last Update Submit

September 25, 2025

Conditions

Colorectal Adenoma

Keywords

Enhanced white light endoscopyAdenoma detection rateRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate (ADR)

    ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy

    14 days

Secondary Outcomes (17)

  • Polyp Detection Rate(PDR)

    14 days

  • Sessile serrated lesion detection rate (SDR)

    14 days

  • Advanced Adenoma Detection Rate (aADR)

    14 days

  • Mean number of polyps per patient (MPP)

    14 days

  • Mean number of Adenomas per patient(MAP)

    14 days

  • +12 more secondary outcomes

Study Arms (2)

E-WLI

EXPERIMENTAL

Enhanced White Light Imaging

Device: Enhanced White Light Imaging

WLI

PLACEBO COMPARATOR

White Light lmaging

Device: White Light lmaging

Interventions

Enhanced White Light ImagingDEVICE

Use of E-WLI for colon inspection during both insertion and withdrawal phase of colonoscopy

E-WLI
White Light lmagingDEVICE

Use of WLl for colon inspection during both insertion and withdrawal phase of colonoscopy

WLI

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male or female aged 45 to 85
  • \. Patients undergoing colonoscopy for colorectal cancer screening, positive fecal immunochemical test (FIT) results, gastrointestinal symptoms, or follow-up examination after colorectal polyp treatment
  • \. Capable of providing informed consent and agreeing to participate
  • \. Able and willing to follow all research processes

You may not qualify if:

  • \. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
  • \. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
  • \. Have had drug or alcohol abuse or psychological disorders in the past five years.
  • \. Pregnant or lactating patients;
  • \. Known to have polyposis syndrome;
  • \. Patients with gastrointestinal bleeding;
  • \. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
  • Patients with contraindications to tissue biopsy;
  • \. History of allergies to the ingredients in intestinal cleansers;
  • \. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
  • \. Researchers believe that patients are not suitable to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

ACTIVE NOT RECRUITING

The First People's Hospital of Lanzhou City

Lanzhou, Gansu, 730050, China

RECRUITING

The Third Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150030, China

NOT YET RECRUITING

Armed Police Forces Hospital of Sichuan

Leshan, Sichuan, China

RECRUITING

People's Hospital of Bayingolin Mongol Autonomous Prefecture

Korla, Xinjiang, 841000, China

NOT YET RECRUITING

Ningbo Ninth Hospital

Ningbo, Zhejiang, China

RECRUITING

Taizhou First People's Hospital

Taizhou, Zhejiang, 318020, China

NOT YET RECRUITING

Central Study Contacts

Qing-Wei Zhang, MD

CONTACT

021-68383015zhangqingweif@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

May 11, 2025

First Posted

May 18, 2025

Study Start

September 20, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)