There are different bracelet sizes depending on patient age/wrist or ankle circumference.
Yes, the devices come ready to use. The only thing the patient needs to do is to connect the docking station to a wall socket using the power cord supplied and to connect the Ethernet cable (RJ45) to their internet port.
There are no button patients need to interact with, or log-in required.
The devices come along a patient manuel and quick-start guide to guide them through their first time use.
Patient is wearing the sensors during the day, and connects the sensors on the docking station every night. In standard model, encrypted data is automatically uploaded by the station to our cloud (AWS) every night. Before analysis, the data is downloaded to our internal servers in France. The communication channel for data transfer is encrypted using HTTPS and TLS 1.2 protocols. Each upload is verified for size and checked for errors to ensure data integrity.
If the patient cannot or does not accept this automatic upload, data is stored nightly on an encrypted USB drive connected to the device. At the end of the recording period, the clinical site retrieves the USB drive and ships it back to Sysnav. We organize the shipment and cover all transport costs. Authorized Sysnav personnel then upload the data to our secure cloud storage for analysis.
Our CRA team is in charge of monitoring compliance at least twice a week for every patient. In case of incomplete data, the clinical site is immediately contacted to investigate with the patient and our technical support is alerted. If the issue is device-related, a replacement will be organized at Sysnav’s expense.
Finally, to ensure meaningfulness of the results, we have pre-defined thresholds on data quantity: we don’t analyze data if the patient has recorded less than 50h on a recording period.
The data will be kept for a maximum of 25 years after the end of the study, in according with the General Data Protection Regulation (GDPR) requirements.
The data will be only used for the research purposes and not for marketing purposes.
Only Sysnav dedicated and authorized staff can access to the data.
4 (algorithm engineers and data scientists only – management and other functions do not have access to data). In addition, 3 IT admins have a potential access to data, but their access is strictly limited to admin tasks (enforced by organizational measures : trainings, IT admin charter)
Outliers are flagged during the quality check process. Generally, they are not removed unless caused by a rare hardware issue.
The original raw data is produced from sensors collecting data in the patient.
To compute clinical endpoints, it goes through a process described in the analysis SOP including:
No, quality checks are conducted after data collection and transfer. However, automatic checks alert us if issues are detected.
Our QC checks include:
When an alert is raised, our analysis team:
No, data is analyzed retrospectively and transferred periodically according to agreements with sponsors.
Compliance report: to be defined by sponsor (usually, weekly)
Results: to be defined in contract. By default, we provide one interim analysis and one final report for 1 year of recording.
By default, results (i.e., variables aggregated by patient by recording period) are delivered in a csv file. We can also prepare a short presentation of the results.
Analyses reports will be listed in contract and will be customized in the Data Transfer Report.
A compliance report on quantity and quality of data recording is shared with sponsor on a weekly or monthly basis
Yes, interim analysis should be requested at least 4 weeks in advance and will be delivered 2 weeks after cut-off date.
Our standard service is to send two analyses: one interim (usually at halfway of patient enrollment) and one final after LPLV.
Given the study set up and staggered patient enrollment, we might have to review when the interim analysis would be most relevant.
The interim analysis consists of providing you the data (e.g. our variables per patient per recording period) in a readable format so that you can start running some analysis and get a sense of treatment efficacy.
For the final analysis, we do provide our clinical expertise and present you the final deliverable with data visualization and interpretation during a presentation meetings
Patient is wearing the sensors during the day, and connects the sensors on the docking station every night. In standard model, encrypted data is automatically uploaded by the station to our cloud (AWS) every night. Before analysis, the data is downloaded to our internal servers in France. The communication channel for data transfer is encrypted using HTTPS and TLS 1.2 protocols. Each upload is verified for size and checked for errors to ensure data integrity.
If the patient cannot or does not accept this automatic upload, data is stored nightly on an encrypted USB drive connected to the device. At the end of the recording period, the clinical site retrieves the USB drive and ships it back to Sysnav. We organize the shipment and cover all transport costs. Authorized Sysnav personnel then upload the data to our secure cloud storage for analysis.
Our CRA team is in charge of monitoring compliance at least twice a week for every patient. In case of incomplete data, the clinical site is immediately contacted to investigate with the patient and our technical support is alerted. If the issue is device-related, a replacement will be organized at Sysnav’s expense.
Finally, to ensure meaningfulness of the results, we have pre-defined thresholds on data quantity: we don’t analyze data if the patient has recorded less than 50h on a recording period.
Updates are managed through a controlled process that includes impact analysis, testing, and validation to maintain data integrity.
Device configurations remain constant during a study, though minor updates may occur without impacting data. A risk analysis and a validation is performed before doing any release.
The reconciliation plan for recording periods, i.e. the frequency of the controls with actual patient visit dates extracted from sponsor system(s), is defined upon study start with each sponsor.
Yes in case of ‘functional’ upgrade. No in case of security upgrade
Click below to see all characteristics
The variables computed by Syde (inc. SV95c) cannot be reproduced with an alternative device. If a patient wishes not to use the device, these variables will not be computed.
We establish initial recording period dates and adjust them as necessary throughout the study based on patient visits, with regular reconciliations.
It usually takes about three months to finalize the protocol and deploy devices at study sites.
The collection of personal data is restricted to what is strictly necessary for the study. The pseudonymized data collected includes:
For ambulant patients: dominant side (left/right)
For non-ambulant patients: dominant wrist side (left/right), full arm length (left and right), forearm length (left and right)
Sysnav confirms it never has access to identifying data, and the data collected is essential for the analysis required by the sponsor.
Our CRA team is in charge of monitoring compliance at least twice a week for every patient. In case of incomplete data, the clinical site is immediately contacted to investigate with the patient and our technical support is alerted. If the issue is device-related, a replacement will be organized at Sysnav’s expense.
Finally, to ensure meaningfulness of the results, we have pre-defined thresholds on data quantity: we don’t analyze data if the patient has recorded less than 50h on a recording period.
Validation process for computerized systems :
Sysnav is ISO 13485 and ISO 9001 certified, demonstrating our commitment to high standards in quality management. Our Quality Management System (QMS) is overseen by the CTO, who also serves as the Head of Quality, and is supported by a team of quality engineers, including production engineers and PMO staff.
The QMS is built on a Quality Manual and a comprehensive set of Standard Operating Procedures (SOPs) covering various aspects of operations, such as:
To ensure alignment with international standards, including ICH E6(R2), we maintain a dedicated set of healthcare SOPs that cover production, support, and compliance. These are regularly updated by an engineer from our healthcare team to reflect the latest regulations and industry best practices.
No, data is analyzed retrospectively and transferred periodically according to agreements with sponsors.
We have only one licensing package:
We charge 1 license for a year of recording of 1 patient. Full license is due when patient is equipped with the device. If the patient is a screenfail, a rebate is applied
Project management fees are included in our license fee. For your information, please find below the breakdown of our license fee:
The data analysis fee includes the analytics provided during the study (e.g. for each variable defined in the data sharing agreement: analysis per patient; per period; aggregated analysis and presentation of results).
The data sharing agreement will detail specifically the analysis we provide based on your needs for the trial.
We need to specify the kind of data transfer we are talking about:
Integrating these tools can streamline trial design by providing continuous, objective data, which may shorten trial duration or reduce patient enrollment needs, thus potentially lowering costs and accelerating treatment evaluations
If the patient cannot or does not accept this automatic upload, data is stored nightly on an encrypted USB drive connected to the device. At the end of the recording period, the clinical site retrieves the USB drive and ships it back to Sysnav. We organize the shipment and cover all transport costs. Authorized Sysnav personnel then upload the data to our secure cloud storage for analysis.
Yes, the platform can be customized to measure various endpoints beyond SV95C. This flexibility allows it to be adapted for different neuromuscular diseases and mobility-related conditions.
Yes. The 95th percentile of Stride Velocity is a measure of a patient’s peak ambulation capabilities, with similar concept of interest being measured than with the 6MWT. Therefore, SV95C can be relevant in various diseases, where motor impairments are early signs of disease progression. The value of SV95C lies in the increased sensitivity-to-change compared to traditional in-clinic assessments and the higher meaningfulness of the measure as it represents a patient’s true capabilities in their daily life. As of now, SV95C has been used in more than 15 indications, mostly in the neuromuscular and neurological spaces, but also in other indications related to cardiac diseases and obesity.
Finally, to ensure meaningfulness of the results, we have pre-defined thresholds on data quantity: we don’t analyze data if the patient has recorded less than 50h on a recording period.
Sysnav’s technology captures a wide range of data over time, enabling it to factor in variability due to daily changes in patient condition, such as fatigue or temporary illnesses, thus providing a more comprehensive assessment of long-term trends.
SV95C, or Stride Velocity 95th Centile, is a digital outcome measure that calculates the fastest strides taken by a patient over time, specifically targeting the top 5% of strides in their daily environment. It’s designed for clinical trials, primarily for Duchenne Muscular Dystrophy (DMD), and provides a real-world assessment of peak ambulatory performance, thus helping to assess disease progression and treatment efficacy in real-world conditions.
The method involves integrating the two data streams rather than simply averaging them.
Variability depends on time and for the DMD disease the averaged variation stabilizes at 3% after 180 hours (15 days). Thanks to continuous assessment we can reduce the variability. 95th percentile is also the most sensitive value, with the lowest variability.
The device measures power for each upper-limb movement and calculates stride speed for every stride, not as averages. Biomechanical models assess the duration and intensity of movement, factoring in resistance (like moving against gravity). Total effort is the sum of power from each movement.
If the patient cannot or does not accept this automatic upload, data is stored nightly on an encrypted USB drive connected to the device. At the end of the recording period, the clinical site retrieves the USB drive and ships it back to Sysnav. We organize the shipment and cover all transport costs. Authorized Sysnav personnel then upload the data to our secure cloud storage for analysis.
A: Yes, it has. We can share findings under MSA/NDA agreements, though publication timelines are still being finalized.
Yes, it uses x-y-z positioning and a barometer for accuracy, particularly on long flights.
Yes, the median is preferred to reduce variability in rare events like stair climbing in certain conditions.
Yes, we analyze both, though stair descent is more relevant in certain diseases like Angelman Syndrome.
Yes, movement must be sustained for a fraction of a second to count.
It refers to continuous walking distance. We measure the 90th centile of the continuous walking episodes to gauge endurance.
Walking events are based on continuous movement. If a pause occurs, we treat separate walking episodes individually to assess sustained ambulation capacity.
