RecruitingNot Applicable

Clinical Feasibility of the IMES Transradial Prosthesis

United Kingdom3 participantsStarted 2023-01-01

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * (unilateral acquired transradial) amputation * residual limb size requirements to fit investigational device componentry * at least 6 residual muscle locations available for implantation * good compliance with health service (rehabilitation) * willing to undergo surgical implantation of IMES Sensor implants * experience with myoelectric upper limb prostheses * using own myoelectric device approximately 6-8h/day * able to provide informed consent and attend the study visits Exclusion Criteria: * any condition which in the opinion of the investigator poses a risk to health * neurological disorder that may prohibit accurate control * major injury proximal to the level of amputation * neuromuscular disorder * nerve transection or palsy that may cause de-innervation of muscles planned for implantation * allergy to implanted materials * existing active implant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Grip Accuracy

Timeframe: 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.

Trial details

NCT IDNCT04936789

SponsorÖssur Iceland ehf

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01

Contact for this trial

Daire McGuinness, BSc

00441315070097 dmcguinness@ossur.com

View on ClinicalTrials.gov More Amputation trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.