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Technical and Clinical Validation of the WPM-SEMG Prototype

NCT06584084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-19

No results posted yet for this study

Summary

Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles.

Conditions

  • Neuron Disease, Motor

Interventions

DEVICE

WPM-SEMG prototype

Measurements will be done with the rigid matrix. The flexible electrode matrix will be used only on a lower percentage of volunteers depending on the results obtained with the rigid matrix

Sponsors & Collaborators

  • University of Applied Sciences and Arts of Southern Switzerland

    collaborator OTHER

  • Clinical Trial Unit Ente Ospedaliero Cantonale

    collaborator OTHER

  • Alain Kaelin

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06584084 on ClinicalTrials.gov