Los Altos

Researchers are evaluating the ARTAS System, a computer-assisted device, for hair restoration procedures in men diagnosed with androgenic alopecia, specifically those with Norwood-Hamilton grades III to VI. This prospective, multi-center study includes up to four investigational centers and focuses on comparing robotic versus manual hair implantation techniques. The study aims to assess the effectiveness of the ARTAS System in improving hair density after treatment. The treatment involves harvesting follicular hair units, creating recipient sites, and implanting the hair, all assisted by the ARTAS device. Participants are required to cut their scalp hair short (less than 1 mm) in the designated areas for the procedure. The study evaluates the hair restoration process using the device, comparing it to manual implantation methods. Participants will be followed for one year after treatment to monitor changes in hair density. The study includes post-operative follow-up visits to assess outcomes and ensure participant safety. Researchers will measure the change in hair density from before treatment to 12 months post-treatment to evaluate the performance of the ARTAS System.

Researchers are conducting a nationwide, fully virtual observational study called FLOWER to gather and standardize clinical data on rare diseases affecting fewer than 200,000 people in the U.S. This study includes a wide range of rare conditions such as Alpha-Thalassemia, Amyotrophic Lateral Sclerosis, Duchenne Muscular Dystrophy, and Sickle Cell Disease, among others. The goal is to create a comprehensive and up-to-date documentation of these diseases' natural history without burdening patients or healthcare staff with data entry. Participants provide electronic consent and authorize access to their medical records, which are collected from various sources including hospitals, clinics, pharmacies, DNA/RNA sequencing vendors, and electronic health information exchanges. Data from medical records are converted into standardized, machine-readable formats and annotated centrally by study staff. Additional information like imaging files, molecular profiles, and patient or caregiver surveys may also be collected to enrich the dataset. During the study, medical records and other data are continuously updated and reviewed with quality control measures. Researchers will monitor outcomes such as overall survival, medication safety, development milestones, functional and motor abilities, and symptom changes over a five-year period. The study does not require active data entry by physicians, and participation is flexible, allowing patients or their representatives to contribute from anywhere in the U.S.

Researchers are conducting a nationwide, fully virtual observational study called xPEDITE to collect detailed data on patients with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG). The study aims to establish a comprehensive natural history of these diseases to serve as an external control for future drug, device, or biologic treatment development. This sub-study is part of a larger pan-cancer observational protocol called XCELSIOR, and it operates within a regulatory-compliant framework. The study gathers medical records from various sources such as hospitals, clinics, pharmacies, and sequencing vendors through electronic and paper faxes, patient portals, and health information exchanges. These records are converted to electronic formats and annotated centrally by remote study staff using machine learning and standardized medical coding systems. Imaging data like MRI and CT scans, genomics results, and patient- and caregiver-reported questionnaires are also collected. Mobility and neurological assessments are videoed regularly for expert review. Participants provide electronic consent and do not need to enter data themselves. The study tracks clinical features longitudinally from diagnosis to final outcome, including treatments, medications, genomic markers, radiological changes, and quality of life impacts. The primary outcome being measured is overall survival at 12 months. Data collection is ongoing in a secure, compliant electronic system with quality control and verification to ensure accuracy and completeness over time.