Los Altos

Researchers are evaluating the performance of the ARTAS System, a computer-assisted device, in hair restoration procedures for males with androgenic alopecia. This multi-center study aims to compare robotic implantation to manual implantation in terms of hair density improvement over one year. The study focuses on men aged 20 to 70 years diagnosed with Norwood-Hamilton grade III to VI androgenetic alopecia. The treatment involves follicular hair unit harvesting, creating recipient sites, and implanting hair follicles using the ARTAS robotic system. Participants will have their hair cut very short on the scalp areas designated for harvesting and implantation. All subjects receive the same study treatment during the procedure. Participants will be followed up for one year after treatment to assess changes in hair density and the percentage of follicles successfully harvested by the robot. Follow-up visits include post-operative evaluations per protocol. The study monitors the effectiveness of the robotic system compared to manual methods and tracks safety and treatment outcomes throughout the year-long period.

Researchers are conducting FLOWER, a fully virtual, nationwide observational study to collect and analyze clinical data from people with rare diseases. This study aims to gather detailed, standardized medical information in real time from patients with conditions affecting fewer than 200,000 individuals nationwide, including diseases like Alpha-Thalassemia, Amyloidosis, Duchenne Muscular Dystrophy, and others. The study is designed to overcome traditional research challenges by reducing burdens on patients and healthcare providers. Participants contribute by electronically consenting and allowing access to their medical records from various sources, including hospitals, clinics, pharmacies, and genetic testing vendors. Data collected include electronic medical records, imaging files, molecular and genetic information, and patient or caregiver-reported outcomes. The study staff standardize and code this information using recognized medical ontologies to create a comprehensive, longitudinal dataset without requiring data entry from treating physicians. During the study, researchers monitor several outcomes over five years, including overall survival, medication safety, developmental milestones, functional and motor abilities, and symptom changes. The study involves no direct interventions, focusing instead on gathering and analyzing real-world data. Participation is entirely remote and ongoing, with data collected continuously to provide a detailed picture of rare diseases natural history and progression.

Researchers are conducting a nationwide, fully virtual observational study to collect detailed information on diffuse midline glioma DMG, including diffuse intrinsic pontine glioma DIPG. The study aims to establish a clear natural history of these diseases by gathering data from both new and existing patients. This information will serve as an external control for future drug, device, or biologic therapy development programs. The study operates under a regulatory-compliant framework and is part of the broader XCELSIOR protocol.