Clinical Feasibility of the IMES Transradial Prosthesis

Sponsor
Össur Iceland ehf
Study ID
NCT04936789
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • IMES — DEVICE
    Surgical implantation of IMES

Study Details

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

Key Dates

First listed
Jun 23, 2021
Start date
Jan 1, 2023
Status verified
Oct 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Single arm
    Single arm. All subjects will receive the intervention. Comparator device will be subjects' own prosthesis at baseline.

Primary Outcome Measure

Grip Accuracy [ Time Frame: The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months. ]

Central Contacts

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