Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
NCT07325708 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-01-08
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.
Conditions
- Upper Limb Amputation Below Elbow (Injury)
- Wrist Disarticulation
- Transradial Amputation
Interventions
- 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.
Sponsors & Collaborators
-
Cabrini Health, Melbourne, Australia
collaborator UNKNOWN -
ProMotion Prosthetics, Moorabbin, Australia
collaborator UNKNOWN -
Phantom Neuro Inc.
lead INDUSTRY
Principal Investigators
-
Michael Lo, MBBS, FRACS, BSc (Hons) · Cabrini Private Hospital, Malvern, Australia
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
- FDA Device
- Yes
Countries
- Australia
Study Locations
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