Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603948
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging a Parallel Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SFI verus WLI
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 SonoScape39s 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
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 11 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
The primary outcome measure is the ADR defined as the proportion of participants with at least one adenoma per-patient analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None