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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Safety of Phantom X system during the implantation procedure, peri-procedurally, and 9 weeks thereafter [Срок оценки: 9 weeks]
• Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument [Срок оценки: 9 weeks]
• Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument [Срок оценки: 9 weeks]

Вторичные конечные точки (12)

• Safety of Phantom X system during the implantation procedure, peri-procedurally, and 21 weeks thereafter [Срок оценки: 21 weeks]
• Functionality of Phantom X system using standardized Assessment of Capacity for Myoelectric Control (ACMC) instrument [Срок оценки: 21 weeks]
• Functionality of Phantom X system using standardized Targeted Box and Blocks Test (tBBT) instrument [Срок оценки: 21 weeks]
• Phantom X Signal-to-Noise Ratio (SNR) [Срок оценки: 9 weeks and 21 weeks]
• Phantom X algorithm gesture accuracy [Срок оценки: 9 weeks and 21 weeks]
• Phantom X at-home wear duration [Срок оценки: 9 weeks and 21 weeks]
• At-home limb usage pattern using Inertial Measurement Unit (IMU) data [Срок оценки: 9 weeks and 21 weeks]
• Prosthesis control resolution [Срок оценки: 9 weeks and 21 weeks]
• Number of system recalibration events [Срок оценки: 9 weeks and 21 weeks]
• User Satisfaction [Срок оценки: 9 weeks and 21 weeks]
• Robustness of Phantom X system [Срок оценки: 9 weeks and 21 weeks]
• Phantom X ease of use [Срок оценки: 9 weeks and 21 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Австралия · 2 центра

• Cabrini Health Ltd — Malvern
• ProMotion Prosthetics Pty Ltd — Moorabbin

Идентификаторы

NCT: NCT07325708 · PN03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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