Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection

NCT ID: NCT06603948

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 698 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2025-06-25

Brief Summary

Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. This technology, combined in the latest generation SonoScape's endoscopes (SonoScape Co, Shenzhen, China) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with SFI are encouraging but are scanty and limited to back-to back studies.

This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI is superior to WLI endoscopy in terms of adenoma detection

Detailed Description

45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of colonoscopy. All procedures are performed with a high-definition HD-580 series videocolonscopes with or without magnification (SonoScape Co, Shenzhen, China).

The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Conditions

Colorectal Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

SFI

Spectral Focused Imaging

Group Type: EXPERIMENTAL

Spectral Focused Imaging

Intervention Type: DEVICE

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

WLI

White Light Imaging

Group Type: PLACEBO_COMPARATOR

White Light Imaging

Intervention Type: DEVICE

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

Interventions

Spectral Focused Imaging

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

Intervention Type: DEVICE

White Light Imaging

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1. Male or female aged 45 to 85
• 2. Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
• 3. Capable of providing informed consent and agreeing to participate
• 4. Able and willing to follow all research processes

Exclusion Criteria

• 1. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
• 2. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
• 3. Pregnant or lactating patients;
• 4. Known to have polyposis syndrome;
• 5. Patients with gastrointestinal bleeding;
• 6. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
• 7. Patients with contraindications to tissue biopsy;
• 8. History of allergies to the ingredients in intestinal cleansers;
• 9. 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.
• 10. Researchers believe that patients are not suitable to participate in the trial;
• 11. Have had drug or alcohol abuse or psychological disorders in the past five years.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role: collaborator

Nanchong Central Hospital

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role: collaborator

West China Forth Hospital

UNKNOWN

Sponsor Role: collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role: collaborator

Seventh Medical Center of PLA Army General Hospital

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Li

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The People'S Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science

Wuhan, Hubei, China

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

West China School of Public Health West China Fourth Hospital

Chengdu, Sichuan, China

NanChong Center Hospital

Nanchong, Sichuan, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

LY2024-136-C

Identifier Type: -

Identifier Source: org_study_id