NCT06603948

Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection

Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging: a Parallel Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Spectral Focused Imaging	Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy
DEVICE	White Light Imaging	Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-04-30
• Completion: 2025-06-25
• First posted: 2024-09-19
• Last updated: 2025-07-02

Locations

8 sites across 1 country: China