An observational study in Neuropathy, sponsored by Withings. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Withings · Observational
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 177 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Withings is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
In and out patients from endocrinology and neuropathy departments
Two type of patients are included in the study :
Exclusion Criteria:
Vulnerable subjects according to the French regulation in force:
Patient diagnosed with diabetes
Diagnostic Test: Neuropathy measurement
Patient diagnosed with neuropathy without diabetes
Diagnostic Test: Neuropathy measurement
Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.
Sudomotor dysfunction diagnostic performance evaluation
The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction).
Time frame: 10 months
Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.
The root-mean-square error (RMSE) and the mean absolute error (MAE) between the sudomotor function value measured by the Withings WBS08 and the Sudoscan as reference on each foot and by averagin g both feet.
Time frame: 10 months
Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires
The correlation between diabetes neuropathy questionnair es and Withings WBS08.
Time frame: 10 months
Safety use of this device
The rate of adverse effects.
Time frame: 10 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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