Phantom X EMG Sensor Implant for Upper-Limb Prosthesis Control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study evaluates the Phantom X Implantable EMG Sensor System in adults with unilateral transradial or wrist-disarticulation amputations. It is a prospective, single-arm, open-label feasibility trial examining surgical feasibility, device function, signal quality, and intuitive prosthetic control during functional tasks. Participants receive the implanted sensor array and telemetry module, activate and calibrate the system, then use a compatible prosthetic hand with periodic assessments of performance and safety. Outcomes include functional measures, device-related safety, and patient-reported quality of life and user experience.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient has a significant cognitive deficit resulting in inability to follow study directions.
2. 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.
3. 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.
4. The patient has a planned medical procedure (e.g., surgery) during the study period that could interfere with compliance with study visits or assessments.
5. Patient has an allergy to anesthesia or other medication used for sedation in the study.
6. Patient has an active implantable device (e.g. cardiac pacemaker, neuromodulation device) that can potentially interfere with the performance of Phantom X system.
7. Patient may require an MRI during the study duration.
8. Implantation of the device poses a health risk to the patient as determined by the implanting physician.
9. 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.

Where it's running

• Cabrini Health Ltd
  Malvern, Victoria, Australia Recruiting
• ProMotion Prosthetics Pty Ltd
  Moorabbin, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Michael Lo, MBBS, FRACS, BSc (Hons) — Cabrini Private Hospital, Malvern, Australia
• Study coordinator: Vinod Sharma, PhD
• Email: vinod@phantomneuro.com
• Phone: +1 512-763-0152

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting TASKA Prosthetics · Multiple Locations · NCT07876115

• Optimize how you control a powered upper-limb prosthesis

  This study tests new electrode configurations to improve myoelectric control for people with a below-elbow amputation using a prosthetic arm.

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• Effect of EMG sensor number and placement on control of below-elbow prosthetic arms

  This project will test whether changing the number and placement of myoelectric sensors helps adults with below-elbow limb absence control a prosthetic arm better while wearing a real device.

  Recruiting Liberating Technologies, Inc. · Chicago, Illinois and 1 other locations · NCT07011420

• One-handed video game controller adapter for children with limb differences

  This study is testing a new one-handed video game controller adapter to see if it helps children with limb differences enjoy and play games like Minecraft better.

  Recruiting University of Manitoba · Winnipeg, Manitoba · NCT05981664

• Understanding the experiences of upper limb prosthesis users

  This study is trying to understand how people who use upper limb prostheses feel about them and what affects their acceptance, to help match them with the right devices and improve their quality of life.

  Recruiting Louis Stokes VA Medical Center · Cleveland, Ohio · NCT04855214

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.