This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
This study is designed to assess the 10-year post-surgery implant survivorship of Total Knee Arthroplasty (TKA) procedures performed using the LEGION Medial stabilized insert, which is FDA approved. Implant survivorship is defined as all of the knee-implanted components without a need for a revision. Questionnaires will be used up to 10 years after surgery to find more about the safety and performance of the device.
The purpose of this research is to assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
This is a prospective single-arm post-market multicenter study to evaluate
clinical outcomes of Cohealyx when used to manage full thickness wounds
post-surgical excision. Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will
undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury. Once Cohealyx has successfully integrated into the wound bed, the wound will be prepped and autografted per standard of care.
The study is a 48-week clinical study to compare study medication NTX-001 used intraoperatively to promote nerve regeneration compared to the standard of care on surgery for acute nerve damage in the hand on subjects between the ages of 18 to 80 years old. Subjects who present with sever nerve damage of the hand and need surgery to repair the nerve damage within 48 hours of injury. After surgery, subjects will complete 12 total study visits: 6 in person and 6 additional telehealth visits. During the in-person clinic visits, subjects will be assessed by physical examinations, vital signs, safety laboratory assessment and complete questionnaires. Subjects with motor/mixed motor injury will also complete an EMG and NCV assessments with an Occupational Therapist at 2 of the in-person visits. During the telehealth visits, subjects will complete questionnaires.
The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.
This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.
This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.
This study is enrolling subjects with coronary artery disease (blockages in the arteries that supply blood to the heart) who need to undergo a procedure called a Percutaneous Coronary Intervention (PCI) to open up a blocked heart artery. At times, a heart pump is used during a PCI to help reduce the work the heart during the procedure. This study is evaluating a heart pump called the KARDION CORY P4 pump. The KARDION CORY P4 pump is investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). This study will randomize subjects, meaning assign by chance, to receive either the KARDION CORY P4 pump or the Impella CP, which is commercially available.
Study participation will last about 30 days and include up to 6 visits. The study includes blood work, questionnaires, an electrocardiogram (ECG) - a tracing of the heart's electrical activity and an echocardiogram (Echo) - an ultrasound test of the heart.
Risks include risks related to the study device including bleeding, infection, and injury to the blood vessel where the device is placed. There are also risks related to study procedures. There may be benefit and the information learned may benefit others in the future.