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TRACE4OC
TRACE4OC
DeepTrace Technologies Srl
TRACE4OC provides the woman's level of risk (very low risk or medium-high risk) of being affected with ovarian cancer at the date of the TRACE4OC-processed USI investigation of an adnexal mass, combined with the serum level test for Cancer Antigen 125 (CA-125), performed no earlier than and no later than one month from the USI study, and with the current woman’s menopausal state (premenopausal or post menopause).
Information source:
Vendor
Last updated:
Nov. 18, 2021
General Information
Technical Specifications
Regulatory
Market
Evidence
General Information
General
Product name
TRACE4OC
Company
DeepTrace Technologies Srl
Subspeciality
Abdomen
Modality
Ultrasound
Disease targeted
Ovarian cancer
Key-features
Classification of risk of having ovarian cancer
Suggested use
During: report suggestion
After: diagnosis verification
Technical Specifications
Data characteristics
Population
Women at risk of ovarian cancer on the recommendation of gynecology specialists
Input
Transvaginal US, 2D, single slice, ovarian mass, CA-125
Input format
DICOM
Output
Classification of medium-high risk vs very low risk, automated report
Output format
PDF
Technology
Integration
Stand-alone third party application
Deployment
Locally on dedicated hardware
Trigger for analysis
On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time
3 - 10 seconds
Regulatory
Certification
CE
Certified, Class I
, MDD
FDA
No or not yet
Intended Use Statements
Intended use (according to CE)
TRACE4OC is indicated for women at risk of ovarian cancer on the recommendation of gynecology specialists. Physicians with expertise with pelvic US can use TRACEOC to support the reporting on US-detected adnexal masses investigations in these subjects. Specialists in gynecology can use TRACE4OC as an aid to diagnosis. TRACE4OC software provides the subject level of risk (very low risk or medium-high risk) of being affected with ovarian cancer at the date of the TRACE4OC-processed US investigation of an adnexal mass, combined with the serum level test for Cancer Antigen 125 (CA-125), performed no earlier than and no later than one month from the US study, and with the current woman’s menopausal state (premenopausal or post menopause). However, it should be noted that DeepTrace Technologies S.R.L. considers TRACE4OC as a support to gynecology specialists in their diagnosis, and as a support to physicians with expertise with pelvic US in their reporting on adnexal masses. These medical professionals keep the final decision-making responsibility.
Market
Market presence
On market since
05-2021
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model
Subscription
Based on
Number of users, Number of installations
Evidence
Evidence
Peer reviewed papers on performance
A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125
(read)
Non-peer reviewed papers on performance
Other relevant papers