Silhouette delivers the data accuracy you need to prove your endpoints

  • Precise area (2D) and volume (3D) measurements
  • Clear, consistent images
  • Accurate, reliable data across users
  • Infection control

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Silhouette

High Quality Data

Images

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.

Automatic Boundary Detection

The automatic wound boundary detection tool reduces the time spent tracing wounds and inter-rater variability.

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
  • Saves time
  • Provides consistency
  • Editable
  • 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

Automatic Boundary Detection

  • Provides tracing and measurement consistency across sites and clinicians
  • Reduces assessment times
  • Editable points on the boundary tracing enable clinicians to manually adjust the boundary if necessary

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A Choice of End-User Devices

  • SilhouetteStar Scanning Device
  • SilhouetteLite+ App on an iPad or iPhone
  • SilhouetteLite App on an iPad or iPhone

SilhouetteStar Scanning Device

  • 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 devices

SilhouetteLite AppSilhouetteLite+ 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 AppSilhouetteLite 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

SilhouetteLite AppSilhouetteCentral 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 165 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

Silhouette for De-centralized Trials

SilhouetteCentral
Research Site 1
Subject's Home
Nursing Home
CRO
How Silhouette Works

Our Clinical Research Services

We create exceptional relationships with our customers, delivering valuable insights to optimize your trial data collection. We collaborate with your team throughout your trial and provide data review services to ensure you get the best quality data.

Clinical Resource Services

Insights

With more than 13 years experience in clinical trials, our services team can provide valuable insights to optimize your trial outcomes.

  • Consulting
  • Investigator Meeting
  • System Design
  • Site Initiation Visit
  • Training
  • Audit Support

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Insight

“The ARANZ project team were great during the start-up phase. They provided clear input when we were making decisions about how to implement the SilhouetteStar system for our trial and worked seamlessly with our CRO on technical integration.”

Anthony Bishop
Project Director, Factor Therapeutics

Collaborate

We work with you to manage the scope, risks, costs, and quality of your trial data from beginning to end.

Collaborate

“The ARANZ support team were clearly very experienced at technical guidance and at assistance for clinical trials, and were easily able to solve technical issues we had in our study. This support service saved us a lot of time and effort and we were able to easily support the users in a timely manner, and with minimal delay or inconvenience.”

Dr. Yael Katz-Levy
Clinical Project Manager, Mediwound

  • Project Management
  • Quality Control
  • Notifications
  • Data Cleansing & Curation
  • Service Desk
  • Refresher Training
  • Individualized Support Services

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Review

The quality of your study data is our priority. Our systems and services provide periodic checks on your image quality and measurements with quick feedback for timely adjustments to your processes if necessary.

  • Data Transfer
  • Data Blinding
  • Independent Assessor
  • Interim Analysis
  • Data Archive

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“There was no room for any errors in the way we gathered or reported the data. So, having the ability to have the data checked and validated by an independent assessor was key to our decision to use Silhouette. The ARANZ Medical team were great to work with and the Silhouette system was easy to use and provided accurate information – both of these elements played important roles in the success of our study.”

Prof. Margit Mahlapuu
Chief Scientific Officer, Promore Pharma

Review

What Our Customers Say

Data Accuracy

“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, USA

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, West Africa

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, USA

Regulatory Approvals

Silhouette has the following regulatory approvals:

Silhouette also supports compliance with the Code of Federal Regulations (CFR), 21 CFR Part 11 and HIPAA

ARANZ Medical has ISO 13485:2016 Certification

Silhouette Customer Stories

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How Silhouette Works

Silhouette can be used with a range of point of care devices depending on your needs.

Overview video thumbnail

What does ARANZ Medical's Silhouette solution do?

A short explainer video about ARANZ Medical's Silhouette wound and skin assessment solution.

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Our Partners

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