Spectral Focused Imaging Versus White Light Imaging in Co... | NCT06603948

Studies
Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection

NCT06603948

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Completed

Last Update Posted

Jul 2, 2025Actual

Enrollment

698Actual

Phase

Not Applicable

Conditions

Colorectal Adenoma

Interventions

Spectral Focused Imaging
White Light Imaging

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2024Actual

Primary Completion Date

Apr 30, 2025Actual

Completion Date

Jun 25, 2025Actual

First Submitted Date

Sep 10, 2024

First Submission Date that Met QC Criteria

Sep 18, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2025

Last Update Posted Date

Jul 2, 2025Actual

Name	Class
First Affiliated Hospital of Ningbo University	NETWORK
Nanchong Central Hospital	OTHER_GOV
First Affiliated Hospital of Xinjiang Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

698Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SFI	Experimental	Spectral Focused Imaging	Device: Spectral Focused Imaging
WLI	Placebo Comparator	White Light Imaging	Device: White Light Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spectral Focused Imaging	Device	Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy	SFI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Polyp Detection Rate(PDR)	Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.	14 days
Sessile serrated lesion detection rate (SSLDR)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital		Beijing	Beijing Municipality	100700	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42260471	Derived	Zhang QW, Liao J, Zeng X, Yi N, Li N, Zhang T, Liu M, Ye G, Yao P, Chou J, Hu C, Li XB. Spectral focused imaging enables enhanced colorectal adenoma detection: a multicenter, parallel randomized controlled trial. BMC Med. 2026 Jun 8. doi: 10.1186/s12916-026-04977-8. Online ahead of print.