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Active clinical trials for "Necrosis"

Results 411-420 of 516

Fitmore Hip Stem PMCF Study: A Multi-centre, Non-comparative, Prospective Post-market Clinical Follow-up...

OsteoarthritisAvascular Necrosis2 more

A multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the Zimmer Fitmore Hip Stem.

Completed8 enrollment criteria

Hot AXIOS System Japan Post Market Survey

Pancreatic Pseudocyst InfectionPancreatic Pseudocyst2 more

To detect information of Adverse Events and Device Malfunctions under real world medical condition in Japan.

Completed2 enrollment criteria

Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery

Acute Renal FailureAcute Kidney Tubular Necrosis1 more

Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF involving distress and destruction of tubular cells. This specific typology of ARF may evolve toward Chronic Renal Failure (CRF) concretizing a major public health issue. Predict the progression of ARF towards CRF appears essential. The investigators believe that the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk towards CRF.

Completed6 enrollment criteria

Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study

Primary and Secondary CoxarthrosisDysplasia Coxarthrosis1 more

The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

Completed17 enrollment criteria

Novel Application of Indocyanine Green as a Biomarker to Identify Tissue Necrosis in Mastectomy...

Breast CancerNecrosis

Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018. The success of this procedure, however, is limited by its complications, including mastectomy skin flap necrosis, which occurs at a rate a 10-15%. Mastectomy skin flap necrosis causes significant morbidity in patients undergoing breast reconstruction, potentially compromising results and delaying oncologic management. In addition, necrosis can lead to infection, implant loss, and need for reoperation. Current approaches to identify mastectomy skin flap necrosis rely largely on the surgeon's assessment of skin flap color, capillary refill, temperature turgor and dermal bleeding. However, clinical assessment of necrosis is subjective and is not a reliable predictor of postoperative complications. ICG microangiography is an accepted adjunct method to aid in clinical judgment by identifying poor perfusion as a surrogate marker for tissue at risk for necrosis during reconstructive surgical procedures. However, transient alterations in blood flow seen by this method may not represent actual necrosis. Furthermore, the common practice of using vasoconstriction methods to prevent massive blood loss in plastic surgery also alters microperfusion and renders the microangiography inaccurate. There is an unmet need for reliable methods to identify mastectomy skin flap necrosis during or post breast reconstruction procedure in order to improve patient outcomes. Recently in animal models of burn or ischemic injuries, ICG dye was shown to preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue, when imaged a day after injection rather than minutes after injection, as is standard for microangiographic use of ICG. This necrosis-avid property of ICG has broad translational potential for clinical use in a variety of disease processes that result in necrosis. However, no clinical application of the necrosis-avid property of ICG has been reported yet. In this study, the investigator will test the feasibility of combining the necrosis-avid property of ICG and the SPY imaging system at University of Wisconsin hospital to obtain delayed imaging of ICG fluorescence for direct necrosis detection in breast reconstruction in mastectomy patients. This project is an early feasibility study to establish whether ICG imaging, in a delayed fashion, can be used in mastectomy patients to aid in the detection of necrotic tissue in breast reconstruction wounds. Investigators will use the preliminary data generated from this pilot study to generate hypotheses and to power future studies.

Completed8 enrollment criteria

Laser Ablation After Stereotactic Radiosurgery

Metastatic Brain TumorsProgression2 more

The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study will include patients with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and, where feasible, healthcare utilization data for publication.

Completed12 enrollment criteria

Observational Study Evaluating Outcomes of Hip Arthroplasty Using Tornier Dual Mobility Acetabular...

Primary OsteoarthritisPost-traumatic Osteoarthritis of Hip Nos3 more

The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.

Completed4 enrollment criteria

A Clinical Investigation of the C2a-Taper™ Acetabular System

OsteoarthritisAvascular Necrosis2 more

The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

Completed2 enrollment criteria

Near Infrared Imaging and Flap Necrosis

Flap Necrosis

Skin flaps following mastectomy breast surgery that do not have enough oxygen are at risk for necrosis which can increase wound healing problems, postoperative recovery time and be costly to the hospital systems and affect the patient quality of life, poor esthetic results and overall reconstructive success. Mastectomy skin flap necrosis (MSFN) has an incidence of 10-15% with higher rates (7% - 30%) in mastectomy procedures with immediate reconstruction. Intraoperative assessment of the circulation in skin flaps is currently done with clinical assessment tools utilizing somewhat subjective identifiers such as flap color, capillary refill, temperature and dermal edge bleeding to determine the viability of the flap. Several technologies have been developed to assist in the clinical judgement of skin flaps but these technologies are not yet widely used because of the cost of the technology, the time required to image the patient, the intravenous injection of indocyanine green (ICG) dye required for contrast and the inability to image repeatedly and in different environments (pre-op, intra-op and post-op). A new commercially available imaging technology uses NIR spectroscopy to measure regional tissue hemoglobin oxygenation, using images that are taken 12 inches away from the patient. Preclinical data shows that NIR can predict necrosis in flaps but clinical data is needed to characterize and assess the value of the technology in plastic and reconstructive surgery. The purpose of this research study is to explore the ability of NIR imaging to predict skin flap tissue viability in the clinical setting of immediate breast reconstruction procedures. Study Design: This is a prospective, non-interventional study that will explore the ability of NIR imaging to predict of tissue viability in immediate breast reconstruction procedures. Necrosis will be scored using the SKIN score. Participation in the study will not impact patient care; all patients will receive standard care.

Completed4 enrollment criteria

Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted...

Radiation InjuryRadiation Necrosis

Using a multi-echo gradient echo sequence to calculate R2* and quantitative susceptibility maps and well as susceptibility-weighted imaging post processing the investigators hypothesize that the investigators would be able to distinguish between pseudoprogression and true progression with the use of an easily implementable sequence on clinical MRI scanners.

Completed9 enrollment criteria
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