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

NCT07325708 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PN03
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Upper limb amputation; Prosthesis; Myoelectric

Outcome Measures

Primary Outcomes (3)

• Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter

  Safety is characterized by collecting device and procedure related adverse events during device implantation and 9-week study follow-up.

  9 weeks

• Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument

  Average and standard deviation of ACMC scores will be computed for all participants

  9 weeks

• Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument

  Average and standard deviation of tBBT scores will be computed for all participants

  9 weeks

Secondary Outcomes (13)

• Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter

  21 weeks

• Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument

  21 weeks

• Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument

  21 weeks

• Phantom X Signal-to-Noise Ratio (SNR)

  9 weeks and 21 weeks

• Phantom X algorithm gesture accuracy

  9 weeks and 21 weeks

Study Arms (1)

Phantom X

EXPERIMENTAL

Device: Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control

Interventions

Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control DEVICE

Participants receive the Phantom X implantable EMG sensor array and telemetry module to enable myoelectric control of an upper-limb prosthesis.

Phantom X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a unilateral upper-limb difference (congenital or acquired) at the transradial or wrist level.
• The patient currently uses a myoelectric prosthesis or is deemed a suitable candidate for fitting with a myoelectric prosthesis.
• Patient is a suitable candidate for the implantation of the Phantom X sensor array as assessed by the implanting physician.
• Patient is at least 18 years old and can provide written informed consent.
• Patient is willing to comply with study protocol and make required study visits.
• Patient received amputation ≥ 12 months prior to consent.

You may not qualify if:

• Patient has a significant cognitive deficit resulting in inability to follow study directions.
• Patient has a neuro-muscular deficit and is unable to initiate substantial muscle contraction in the residual limb as determined by the implanting physician or investigator.
• Patient has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
• The patient has a planned medical procedure (e.g., surgery) during the study period that could interfere with compliance with study visits or assessments.
• Patient has an allergy to anesthesia or other medication used for sedation in the study.
• Patient has an active implantable device (e.g. cardiac pacemaker, neuromodulation device) that can potentially interfere with the performance of Phantom X system.
• Patient may require an MRI during the study duration.
• Implantation of the device poses a health risk to the patient as determined by the implanting physician.
• Women who are breastfeeding, currently pregnant or planning to become pregnant during the duration of the study or have a positive urine pregnancy test at screening.

Sponsors & Collaborators

• Phantom Neuro Inc.: lead
• Cabrini Health, Melbourne, Australia: collaborator
• ProMotion Prosthetics, Moorabbin, Australia: collaborator

Study Sites (2)

Cabrini Health Ltd

Malvern, Victoria, 3189, Australia

Location

ProMotion Prosthetics Pty Ltd

Moorabbin, Victoria, 3189, Australia

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Michael Lo, MBBS, FRACS, BSc (Hons)

  Cabrini Private Hospital, Malvern, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinod Sharma, PhD

CONTACT

+1 512-763-0152; vinod@phantomneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

AU (2)