Study of the Phantom X Implantable EMG Sensor System for Control of Upper-Limb Prostheses in Adults with Transradial or Wrist Amputation

What this Trial Is About

Researchers are evaluating the Phantom X System, an implantable electromyography EMG sensor array designed to help control upper-limb prostheses, in individuals with unilateral transradial amputation or wrist disarticulation. This early-feasibility, single-group, open-label study aims to assess the safety, surgical feasibility, device function, signal quality, and ability of the system to support intuitive myoelectric prosthetic control during functional tasks. Participants will undergo surgical implantation of the Phantom X EMG sensor array and telemetry module. After implantation, the device will be activated, calibrated, and integrated with a compatible prosthetic hand. The study includes a series of in-clinic visits to evaluate EMG signal quality and the functional performance of the system using standardized assessments. Patient-reported outcomes such as quality of life and user experience will also be collected. Safety will be monitored through adverse event reporting and system performance checks. During the study, participants will attend multiple visits to complete functional assessments like the Assessment of Capacity for Myoelectric Control ACMC and the Targeted Box and Blocks Test tBBT. Researchers will measure safety up to 9 and 21 weeks after implantation, along with device performance metrics including signal-to-noise ratio, gesture accuracy, prosthesis control resolution, recalibration events, at-home wear duration, and user satisfaction. The total participant involvement lasts at least 21 weeks following implantation to monitor safety and system functionality.

Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control