Dolbeau-mistassini, Canada
Product Surveillance Registry
Phase
N/ASpan
1466 weeksSponsor
MedtronicMorristown, New Jersey
Recruiting
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Phase
N/ASpan
3027 weeksSponsor
MedtronicMorristown, New Jersey
Recruiting
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
The study is an observational study of patients with mitral regurgitation undergoing LHC prior to mitral valve surgery or percutaneous mitral valve intervention. Prior to patients LHC they will undergo testing using CMR, CPET, and KCCQ. During the LHC, patients will undergo evaluation of intracardiac pressures and volumes using a specialized catheter which measures pressure and volume changes throughout the cardiac cycle. CMR- CMR evaluation will quantify mitral regurgitant volume and fraction, right and left atrial size and function, and myocardial scar quantification. CPET- objectively assess patients exercise capacity. KCCQ- is a standard questionnaire designed to assesses patients quality of life and symptom burden. LHC- Pressure-volume loops will be measured during LHC. This will quantify left ventricular compliance and assess patients for the presence of diastolic dysfunction. These evaluations will help us better understand the relationship between symptoms, exercise capacity, severity of MR and diastolic dysfunction.
Phase
N/ASpan
122 weeksSponsor
Atlantic Health SystemMorristown, New Jersey
Recruiting
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
The Siegel™ Transcatheter Aortic Valve (TAVR) Early Feasibility Study is a prospective, non-randomized, single-arm, multi-center study conducted in the US. The primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Phase
N/ASpan
55 weeksSponsor
MiRusMorristown, New Jersey
Recruiting
A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
People with Cystic Fibrosis (pwCF) who are genetically ineligible and/or not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulators currently face future health that is considerably different from the approximately 90% of pwCF in the United States who benefit from CFTR modulators. New treatments are being advanced for pwCF who are genetically ineligible or not taking CFTR modulators and these therapies will include both nucleic acid-based therapies (NABTs) to address the underlying defect in CFTR and symptomatic therapies aimed at targeting the symptoms of CF. A key concern for this limited and underserved patient population is being able to advance multiple therapeutic programs in parallel. To complete these studies, CF researchers will need to be able to reach this community effectively while also promoting the use of innovative trial designs. The REACH Study is a prospective, longitudinal, observational research study to obtain research quality (i.e., monitored research) CF outcome data. Primary outcome endpoints of the Core study (collected across all study participants) are aligned with anticipated clinical trial outcome endpoints needed in overall development of therapies for the CF population unable to benefit from CFTR modulators. This study will also include sub-studies to obtain specialized measures which may help inform efficacy and safety evaluations of new therapies by providing CF control data. Finally, this study also seeks to assess research solicitation and research participation for the CF population that is modulator ineligible or not taking modulators. The observational data collected within this study may be used in characterizing this CF population, developing innovative trial designs, for comparison when evaluating new or experimental CF therapies, and/or in CF research.
Phase
N/ASpan
256 weeksSponsor
Nicole HamblettMorristown, New Jersey
Recruiting
Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
Phase
2Span
150 weeksSponsor
Stingray TherapeuticsMorristown, New Jersey
Recruiting
AltaValve Pivotal Trial
Phase
N/ASpan
369 weeksSponsor
4C Medical Technologies, Inc.Morristown, New Jersey
Recruiting
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Phase
2Span
288 weeksSponsor
Regeneron PharmaceuticalsMorristown, New Jersey
Recruiting
Pancreatic Cancer Detection Consortium
Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. It often goes undetected until it is at an advanced stage, making it challenging to treat. Currently, only a small percentage of patients are diagnosed early enough for effective treatment. While a blood marker exists, called serum carbohydrate antigen 19-9 (CA19-9), it is used primarily to track the disease and it is unreliable for early detection. To address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called microRNAs (miRNAs). In a previous study, by analyzing both the miRNAs that circulate freely in serum and the miRNAs that are inside the exosomes, the researchers have already identified a combination of 13 miRNAs that could accurately detect early-stage PDAC. In this study, the researchers will test this method in a larger international cohort study. This study aims to confirm the effectiveness of this approach in accurately identifying PDAC at its earliest stages.
Phase
N/ASpan
141 weeksSponsor
City of Hope Medical CenterMorristown, New Jersey
Recruiting
Healthy Volunteers
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.
Phase
N/ASpan
119 weeksSponsor
Atlantic Health SystemMorristown, New Jersey
Recruiting