Moorabbin

Researchers are evaluating the Phantom X System, an implantable electromyography EMG sensor array designed to help control upper-limb prostheses, in individuals with unilateral transradial amputation or wrist disarticulation. This early-feasibility, single-group, open-label study aims to assess the safety, surgical feasibility, device function, signal quality, and ability of the system to support intuitive myoelectric prosthetic control during functional tasks. Participants will undergo surgical implantation of the Phantom X EMG sensor array and telemetry module. After implantation, the device will be activated, calibrated, and integrated with a compatible prosthetic hand. The study includes a series of in-clinic visits to evaluate EMG signal quality and the functional performance of the system using standardized assessments. Patient-reported outcomes such as quality of life and user experience will also be collected. Safety will be monitored through adverse event reporting and system performance checks. During the study, participants will attend multiple visits to complete functional assessments like the Assessment of Capacity for Myoelectric Control ACMC and the Targeted Box and Blocks Test tBBT. Researchers will measure safety up to 9 and 21 weeks after implantation, along with device performance metrics including signal-to-noise ratio, gesture accuracy, prosthesis control resolution, recalibration events, at-home wear duration, and user satisfaction. The total participant involvement lasts at least 21 weeks following implantation to monitor safety and system functionality.

This research aims to evaluate the long-term safety and effectiveness of the Rigicon Infla 10 Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction ED. ED is a common male sexual condition linked to various health issues such as diabetes, cardiovascular disease, and depression, affecting quality of life. The study follows patients implanted with this device for up to three years to assess its impact on ED treatment. Participants receive the Rigicon Infla 10 inflatable penile prosthesis, which is a three-piece device designed to help men achieve and maintain erections. The study involves a single group of male subjects aged 22 and older who have been implanted with this device. Follow-up visits are scheduled at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months post-implantation to monitor safety and device effectiveness. During the study, participants will have assessments including device-related safety events, an objective axial rigidity test at 12 months, and evaluations of erectile function and self-esteem using standardized questionnaires. Researchers will monitor participants according to the study protocol and usual care for ED and related health conditions. The total participation period spans up to three years with periodic health evaluations and device durability assessments.