Silhouette enables users to easily and quickly gather consistent images of the skin/soft tissue or wound.
Measurements
3D measurements captured by SilhouetteStar are automatically calculated in SilhouetteCentral software for analysis and reporting.
Reporting
Silhouette makes it easy to report on healing trends.
Secure
SilhouetteCentral is a secure online database for all information.
SilhouetteStar laser lines guide users to take consistent images
Automatic flash ensures consistent lighting across images
The data required for all measurements are captured with a single push of the button
Multiple images can be taken for multiple wounds
Tracing the wound boundary on the image in SilhouetteCentral ensures accurate measurements
SilhouetteStar uses structured lighting for 3D measurements of wound area, depth and volume
SilhouetteLite+ uses a range finder and planimetry to measure wound area
Studies show Silhouette provides excellent inter-rata and intra-rata reliability
Clear graphs show healing trends in an instant
PDF assessment files make it easy to share information
Tissue type view enables graphs of tissue classifications and details of changes over time
One location for all your information
Easy web-based access
User access profiles ensure trial data is secure
Clinical trial data is anonymised
Easy to Use
A Choice of End-User Devices
SilhouetteStar Camera
SilhouetteLite+ App on an iPad or iPhone
SilhouetteLite App on an iPad or iPhone
SilhouetteStar Camera
Laser guided images ensure correct focus and lighting for consistent images every time
Accurate, 3-D wound/skin measurements
Images and data are instantly and securely uploaded to SilhouetteCentral software for analysis and reporting
Enables measurements on complex body shapes
Wired or wireless SilhouetteStar cameras
SilhouetteLite+ App and Sensor
Consistent images using the camera on your mobile device
Accurate 2-D wound/skin measurements
Images and data are securely uploaded to SilhouetteCentral software for analysis and reporting with a WiFi connection
Detailed notes fields
Portable
User-friendly software
SilhouetteLite App
Consistent images are captured using the camera on your mobile device
Images and data are securely uploaded to SilhouetteCentral software for analysis and reporting with a WiFi connection
Free text fields for simple notes
Portable
User-friendly software
SilhouetteCentral Database
Intuitive workflows for users
Multiple data fields to record subject information
Images and data are securely uploaded from the end-user devices
Configurable software to meet your needs
Anonymized subject data
Reduces Risks
Proven
Silhouette has been used in more than 150 phase I to IV clinical trials.
Complete Record
Ensures accurate, consistent and complete data is available and securely stored for each subject.
Infection Control
Non-contact end user devices ensure optimal patient comfort and infection control.
Experienced
Our services team are always available to help you improve your wound assessment and information management practices.
Assessing treatments for skin conditions, such as, acne, burns, Critical Limb Ischemia (CLI), Epidermolysis Bullosa (EB), Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Assessing agents, including, biological, pharmaceutical, dressing and medical device products
Assessing Venous Leg Ulcers (VLU), Diabetic Foot Ulcers (DFU), Pressure Injuries/ Ulcers (PI/PU), and Buruli Ulcers
Summary information at a glance
Detailed wound healing information
Depth and area measurements
Clear and consistent images
SilhouetteStar camera – wired or wireless
SilhouetteLite+ App – on iPads or iPhones
SilhouetteLite App – on iPads or iPhones
Project Management and System Implementation
Technical & Clinical Training
Data Management
Service Desk
Choosing the right imaging device for a clinical trial can be complex
Follow the link below to get your copy of a white paper that discusses some of the key considerations for choosing an imaging device for clinical trials on skin disruption and wound treatments.
"We found Silhouette intuitively easy to use, and the most important part is that we know that the data we collect will be accurate and securely stored to prove that our visual assessment of wound dimensional changes have an accurate reference point."
Stuart Collyer Senior Development Scientist, Microarray UK
High Quality Data
"Silhouette gives us confidence in the quality and accuracy of our data."
Dr Philippe Foubert Lead Scientist, Cytori Therapeutics
Easy to Use
"The technology is simplifying the capture of images and measurements. It is extremely convenient and proving valuable in rural hospitals in Africa."
Dr Kingsley Asiedu Medical Officer, World Health Organization, Global Buruli Ulcer Initiative
Ensures Data Confidentiality
"The benefits of using Silhouette have been enormous for us. We have been able to accurately provide detailed measurements across all of our research sites, export the data when we needed it, and the secure database of images and measurements enables all clinicians to see how the wounds are healing without compromising patient confidentiality."
Kimberly Dorsch Director, Global Clinical Affairs, LifeNet Health
Silhouette Operates Across Trial Sites
Silhouette Customers
Regulatory Approvals
Silhouette has the following regulatory approvals:
FDA cleared – 510(k) number K070426
Health Canada – Therapeutic Products Directorate
CE Mark
TGA approval (Australia)
WAND registration (New Zealand)
Singapore regulatory clearance
Silhouette also supports compliance with the Code of Federal Regulations (CFR), 21 CFR Part 11 and HIPAA
ARANZ Medical has ISO 13485:2016 Certification
How Silhouette Works
Find out more about our easy to use wound imaging, 3D measurement, and documentation system.