Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04936789

Clinical Feasibility of the IMES Transradial Prosthesis

Led by Össur Iceland ehf · Updated on 2024-10-08

3

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

CONDITIONS

Official Title

Clinical Feasibility of the IMES Transradial Prosthesis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral acquired transradial amputation
  • Residual limb size suitable to fit the investigational device components
  • At least six residual muscle locations available for implantation
  • Good compliance with health service rehabilitation
  • Willingness to undergo surgical implantation of IMES sensor implants
  • Experience with myoelectric upper limb prostheses
  • Using own myoelectric device approximately 6-8 hours per day
  • Able to provide informed consent and attend study visits
Not Eligible

You will not qualify if you...

  • Any condition that poses a health risk as judged by the investigator
  • Neurological disorder that may prevent accurate prosthesis control
  • Major injury above the level of amputation
  • Neuromuscular disorder
  • Nerve transection or palsy causing muscle de-innervation planned for implantation
  • Allergy to implanted materials
  • Existing active implant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, 0000 000

Actively Recruiting

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Research Team

D

Daire McGuinness, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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Clinical Feasibility of the IMES Transradial Prosthesis | DecenTrialz