NCT07325708

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

Clinical Evaluation of System for Bionic Arm Gesture Control (CYBORG)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Phantom Neuro Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses. The study will assess surgical feasibility, device function, signal quality, and the system's ability to support intuitive prosthetic control during functional tasks. Participants will undergo implantation of the Phantom X sensors and complete a series of in-clinic visits to assess functional performance of the Phantom X system. Patient-reported outcomes will also be collected at various timepoints.

Detailed description

This early-feasibility study will evaluate the safety and functional performance of the Phantom X Implantable EMG Sensor System in individuals with unilateral transradial amputation and wrist disarticulation. The system consists of an implanted EMG sensor array, an implanted telemetry module, and an external wearable interface that provides real-time muscle signals to a myoelectric prosthesis. The study follows a prospective, single-arm, open label design. Participants will undergo surgical implantation followed by device activation, calibration, and integration with a compatible prosthetic hand. Study procedures include periodic assessments of EMG signal quality, standardized functional assessments, and patient reported outcomes including quality of life measures and user experience. Safety will be monitored through adverse-event reporting and system performance checks.

Conditions

• Upper Limb Amputation Below Elbow (Injury)
• Wrist Disarticulation
• Transradial Amputation

Interventions

Type	Name	Description
DEVICE	Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control	Participants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated device study