Louisville

Maternal fetal monitoring devices help healthcare professionals track and store important data about the health of both mother and fetus during pregnancy and delivery. This research focuses on evaluating a new maternal fetal monitoring device by collecting clear and continuous fetal heart rates from twin pregnancies. The study compares this new device's readings with those from an existing ultrasound imaging device to support its clinical use. Participants will use two devices: the investigational fetal monitoring device, which is designed to monitor and record various clinical parameters for pregnant women and their fetuses during different pregnancy stages, and a marketed ultrasound imaging device used for general diagnostic measurements. Both devices will collect fetal heart rate data simultaneously from twin pregnancies. During the study, researchers will gather distinct fetal heart rate data and maternal pulse rates over a 40-minute period. Participants must be 18 years or older with a twin pregnancy at 30 weeks gestation or more. The study involves monitoring, storing, and analyzing the collected data to assess the performance of the new device in comparison to the existing ultrasound device.

This research aims to validate the accuracy of the sponsor's SpO2 sensors within the Philips MRI Patient Monitoring Pulse Oximetry Subsystem. The study evaluates sensor performance over a blood oxygen saturation range of 70-100% during non-motion conditions, comparing these readings to reference SaO2 values obtained from CO-Oximetry analysis of arterial blood samples. The study focuses on adults aged 18 to 50 years and includes both males and females of any race. Participants will be monitored using the Philips MR400 Pro MRI Patient Monitor along with various SpO2 sensors and accessories, including the Philips IntelliVue Patient Monitor X3, adult SpO2 gloves, grips, and wireless patient modules. The study involves non-motion testing conditions to assess sensor accuracy, with no drug interventions involved. The primary outcome measure is the SpO2 accuracy assessed during the period from March to April 2026. During the study, participants will undergo arterial blood sampling for CO-Oximetry to serve as a reference standard. Various assessments related to sensor performance and participant health will be conducted, including health screening and verification of sensor application sites. Researchers will monitor vital signs and collect data to evaluate sensor accuracy and safety. The total participation duration and follow-up details are defined by the study protocol to ensure comprehensive validation of the SpO2 sensors.

Researchers are evaluating the performance, clinical benefits, and safety of the Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty (TKA). This study uses a multicenter, single-arm, retrospective cohort design with prospective follow-up to gather data. The study includes patients with knee conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, and other joint issues treated with this knee system. The study focuses on the Persona Revision Knee System implants and related devices used according to their instructions for use. Patients who had the system implanted will be identified retrospectively and invited for prospective follow-up visits at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device became commercially available in late 2019, so past treatments follow standard care. Up to 20 sites will participate with a maximum of 380 patients enrolled. Participants will attend scheduled follow-up visits involving clinical evaluations to measure knee function using the 1989 Knee Society Clinical Rating System objective knee score over 2 years. Researchers will monitor performance improvements, safety, and clinical benefits of the knee system. Data collection will help assess patient outcomes and device effectiveness with long-term monitoring planned up to 10 years.