Esprit BTK Post-Approval Study (PAS)
The purpose of this study is to assess the continued safety and efficacy of the Esprit BTK system, which was recently approved by the Food and Drug Administration (FDA), for treatment of narrowed arteries below the knee in patients with Chronic Limb-Threatening Ischemia (CLTI).
Evaluating a Noise Reduction algorithm with Cochlear Implant Users
In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for 60 cochlear implant users ages 12 and older.
Evaluation of cardiac function with cardio-respiratory synchronized MRI
The purpose of the proposed study is the evaluation of newer methods of performing cardiovascular MRI (CMR). CMR is already being used to demonstrate cardiac abnormalities and assess cardiac function in many patients. The potentially blurring effects of cardiac motion during image data acquisition are reduced by synchronizing the acquisition with the cardiac cycle, typically by monitoring the ECG (gating), and respiratory motion effects are reduced by having the patient suspend respiration during imaging. However, there can be significant technical difficulties with performing CMR, particularly when there is patient difficulty with suspending respiration or in the presence of arrhythmias
EVALUATION OF FREQUENCY ALLOCATION TABLES FOR RECENTLY IMPLANTED SINGLE-SIDED DEAF COCHLEAR IMPLANT USERS
This observational study will examine cochlear implant (CI) patients with single-sided deafness (SSD) who receive non-default frequency allocation tables (FATs) after initial stimulation to determine how it affects performance with the device. Behavioral tests of hearing will be measured longitudinally, and include measures of sound quality, listening effort, device satisfaction, and speech perception abilities.
Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study is to determine if blood or stool can be used todetect colon cancers and advanced colon polyps as early, or earlier, thancolonoscopy. The researchers plan to use these samples to learn aboutspecific proteins biomarkers that may indicate the presence of colon polyps,colon cancer, or an increased risk of developing colon cancer. In order tolearn more about preventing and detecting colon and rectal cancer, we arecollecting samples from subjects with cancer, adenomas, and scheduledcolonoscopies who may be at risk for polyps.
Evaluation of the MISHA Knee System for Symptom Relief in Subjects with Medial Knee Osteoarthritis versus the use of non-surgical treatment: Randomized Assessment and Comparison of Therapies for Medial Knee Osteoarthritis
The purpose of this research study is to evaluate how well the MISHA Knee System helps reduce symptoms of medial knee osteoarthritis compared to non-surgical treatments.
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement
Aortic stenosis is a type of heart valve disease where the valve located between the lower left heart chamber and the body’s main artery (aorta) becomes narrowed and cannot open completely. This narrowing of the valve reduces or blocks the blood flow from the heart to the rest of the body. The treatment for severe aortic stenosis is aortic valve replacement. While aortic valve replacement has traditionally been done through open heart surgery, a less invasive technique called transcatheter aortic valve implantation (TAVI) has become an alternative option for patients. The Navitor TAVI System has been Food and Drug Administration (FDA) approved for patients with symptomatic, severe aortic stenosis who are at high or extreme risk for open heart surgery. The purpose of this research study is to expand the indication of the Navitor TAVI System to patients at intermediate and low risk for open heart surgery. The safety and effectiveness of the Navitor TAVI System will be compared to that of any commercially available transcatheter aortic valve system approved by FDA for treating patients considered intermediate or low risk.
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Surgical Risk Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement
The ENVISION Clinical Trial is studying theNavitor™ Transcatheter Aortic Valve Implantation(TAVI) System in patients with severe,symptomatic aortic stenosis who are deemedlow or intermediate surgical risk. Approximately 1,500 patients will be studied atup to 95 centers globally. A select team ofphysicians will monitor the patients includedin the ENVISION Clinical Trial. Clinical trial participants will play an importantrole in helping physicians evaluate the use of theNavitor TAVI System for patients with severeaortic stenosis.
EVEREST-2: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B694 an Autologous Logic-gated Tmod CAR T in Heterozygous HLA-A*02 Adults with Recurrent Unresectable Locally Advanced or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
econditioning lymphodepletion) for different cancers that express mesothelin (MSLN). First, the study team will test it on a small number of patients to see if it has few side effects and if it is effective in treating the cancers. Then, they'll include more patients to check there are few side effects again and see how well it works. If it seems effective with few side effects, they study team will continue testing it on more patients with different types of cancer. The study team will closely watch how the treatment works for each type of cancer. If it doesn't seem to be helping enough for a specific type of cancer, they might not include more patients with that cancer type. All the patients in the second part of the study will get the best dosage found from the first part of the study.
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