The Global Paradise System US Post Approval Study (US GPS)
The objective of the Global GPS Registry is to evaluate the real-world use of the Paradise System as per approved labeling. In addition, US GPS will collect data in patient populations underrepresented within the RADIANCE clinical program. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients with Complex Iliac Occlusive Disease
To demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study Trial
To assess the safety and effectiveness of the Hancock Jaffe VenoValve for the treatment of patients with deep venous valvular insufficiencyA prospective, non-blinded, single-arm multi-center pivotal study of the Hancock Jaffe VenoValve. All patients will receive optimized care (e.g., appropriate medications, compression therapy) throughout the study.The study will be conducted in accordance with the 2020 Standard ISO 14155 (Clinical investigation of medical devices for human patients - Good clinical practice), and other regulatory and legal requirements.
The HEALthy Brain and Child Development Study (HBCD)
This multi-site consortium research study, entitled the HEALthy Brain and Child Development (HBCD) study, will prospectively examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally through age 10 years. The study will determine the short- and long-term impacts of a variety of potentially harmful as well as protective environmental factors. These include prenatal substance use, mental health, stress, sociodemographics, biological and genetic factors, and parent/child interaction. The overall goal of this study is to understand the neurodevelopmental trajectories of children growing up in diverse environments. A sample of ~7,500 pregnant women will be recruited from 25 sites across the U.S. and they and their liveborn children will be followed for 10 years.
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The Hirschsprung Disease Research Collaborative
Hirschsprung disease (HSCR) is a neurodevelopmental defect resulting from the absence of nerve (ganglion) cells in the gastrointestinal tract. The disorder has a population incidence of 1/5,000 live births and most often occurs as an isolated phenotype. However, approximately 30% of HSCR cases are associated with other birth defects such as Down syndrome, deafness, hypopigmentation, and Congenital Central Hypoventilation syndrome (CCHS, aka Ondine’s curse). Hirschsprung disease is a genetic condition sometimes recognized with autosomal dominant and autosomal recessive inheritance, but is generally multifactorial. While several genes associated with HSCR have been identified, it is expected that additional genes play important roles in the disorder. Furthermore, much remains to be understood about the mechanisms of genetic variants involved in the disease and how variants in multiple genes interact to lead to the diverse forms of HSCR. The objective of the Hirschsprung Disease Research Collaborative (HDRC) is to build a large collection of data and biological samples of individuals with HSCR by which genetic data can be linked to detailed and accurate phenotypic information. HDRC members (surgeon champions at diverse medical centers) will collect samples and data through a multi-site study where Dr. Aravinda Chakravarti’s laboratory at NYU School of Medicine serves as the coordinating center. The data and samples collected by HDRC members will not only be available for genetic studies, but will form a biobank from which HDRC members can request access to de-identified samples and data for use in their own IRB-approved studies. The goal of the genetic studies carried out with HDRC samples is to complete the identification of HSCR susceptibility genes and to better understand the complex inheritance of HSCR in families by whole genome mapping and sequencing studies. We also intend to ascertain the frequency with which HSCR gene variants, individually and together, lead to the diverse forms of HSCR. Finally, we use these results together with the clinical information we collect to investigate possible genotype-phenotype correlations and their relationship with medical, surgical and pathological data on participants.
The HistoSonics Edison System for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY US)
This trial is a prospective, multi-center, single-arm pivotal trial designed to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary solid renal tumors. Data through 90 days for all enrolled subjects will be summarized in a primary analysis to be submitted for Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 14-day, 30-day, 90-day, 180-day and annual time points.
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The impact of postoperative Voice use on vibratory measures in a collaborative observational cohort Study who undergo phonosurgery.
The purpose of this research study is to find the ideal time of voice rest after vocal fold surgery and improve the vocal rehabilitation guidelines.
The IRIS trial: A clinical trial for people living with active lupus nephritis (LN)
IRIS is looking to see if a new FDA-approved therapy called SAPHNELO® may be effective in treating people with active LN. SAPHNELO® is the brand name for the medication anifrolumab. This medication is a monoclonal antibody. It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-a and interferon-B.