Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:42 AM
Study NCT ID:
NCT07211295
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accurate AI-based Characterisation of Surface Size, Depth and Tissue Composition in Hard-to-Heal Wounds
Sponsor:
University Hospital, Linkoeping
Organization:
Study Overview
Official Title:
Accurate AI-based Characterisation of Surface Size, Depth and Tissue Composition in Hard-to-Hea Woundsl
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SeeWound2
Brief Summary:
This study aims to determine and evaluate the clinical accuracy, precision, and safety of SeeWound 2, an AI-driven wound assessment application, designed for the measurement of wound surface area (cm²), wound depth (mm), and the estimation of the proportion of fibrin covering (slough) and necrosis (%) in real-world clinical settings for patients with hard-to-heal wounds. The study also seeks to validate the non-invasive method for measuring wound depth, as current standard care involves invasive probing of the wound to estimate depth - a practice that this investigational device is intended to replace with a digital, contact-free measurement approach.
Detailed Description:
SeeWound 2 is a software-based medical device that utilises artificial intelligence to classify and quantify wound tissue types, specifically fibrin covering (slough) and necrosis, as well as to measure wound surface area and depth through digital image analysis. The system operates as a mobile camera-based application, whereby healthcare professionals capture an image of a hard-to-heal wound. The software then automatically analyses the image using integrated AI models in combination with the LiDAR sensor technology embedded in the mobile camera hardware. The product's capability to automatically measure wound surface area, estimate wound depth in a non-invasive manner, and objectively quantify the proportion of slough and necrosis within the wound bed represents a novel functionality not currently available in clinical practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: