Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT03611361
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2018-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
Sponsor:
SpectralMD
Organization:
Study Overview
Official Title:
Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Able to reach conclusions about feasibility with number of subjects enrolled.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISCR
Brief Summary:
This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.
Detailed Description:
SpectralMD has developed an imaging device (DeepView), which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a CADe algorithm to categorize microvascular blood flow and provide a quantitative assessment to aid in selecting the appropriate amputation site.
The investigators intend to gather data to train the CADe algorithm to predict ultimate healing status of tissue in the lower extremities of individuals suffering from peripheral arterial disease (PAD). The investigators will demonstrate the feasibility of using such an algorithm to accurately predict the location and extent of small vessel disease prior to amputation. Eventually, the invesitgators expect the DeepView to reduce the rate of re-amputation in patients with peripheral arterial disease if used for routine assessment of patients prior to amputation.
The aims of the study are as follows:
* Evaluate performance of a Computer Assisted Detection (CADe) algorithm trained to assist selecting the level-of-amputation in patients with PAD.
* Identify multispectral signatures that are strongly predictive of viable skin tissue at proposed amputation sites.
* Create a representative database for training the CADe algorithm.
The investigators intend to gather data to train the CADe algorithm to predict ultimate healing status of tissue in the lower extremities of individuals suffering from peripheral arterial disease (PAD). The investigators will demonstrate the feasibility of using such an algorithm to accurately predict the location and extent of small vessel disease prior to amputation. Eventually, the invesitgators expect the DeepView to reduce the rate of re-amputation in patients with peripheral arterial disease if used for routine assessment of patients prior to amputation.
The aims of the study are as follows:
* Evaluate performance of a Computer Assisted Detection (CADe) algorithm trained to assist selecting the level-of-amputation in patients with PAD.
* Identify multispectral signatures that are strongly predictive of viable skin tissue at proposed amputation sites.
* Create a representative database for training the CADe algorithm.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: