NCT04936789 Clinical Feasibility of the IMES Transradial Prosthesis
| NCT ID | NCT04936789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Össur Iceland ehf |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2023-01-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis
Eligibility Criteria
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
Contact & Investigator
Aidan Roche, MD
PRINCIPAL INVESTIGATOR
NHS; University of Edinburgh
Frequently Asked Questions
Who can join the NCT04936789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04936789 currently recruiting?
Yes, NCT04936789 is actively recruiting participants. Contact the research team at dmcguinness@ossur.com for enrollment information.
Where is the NCT04936789 trial being conducted?
This trial is being conducted at Glasgow, United Kingdom.
Who is sponsoring the NCT04936789 clinical trial?
NCT04936789 is sponsored by Össur Iceland ehf. The principal investigator is Aidan Roche, MD at NHS; University of Edinburgh. The trial plans to enroll 3 participants.