NCT04936789

Clinical Feasibility of the IMES Transradial Prosthesis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand. Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	IMES	Surgical implantation of IMES

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2021-06-23
• Last updated: 2024-10-08

Locations

1 site across 1 country: United Kingdom