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We list hundreds of Clinical Trials about "Peak Scientific Introduces Genius 1024 SCIEX Approved Generator" on BioPortfolio. We draw our references from global clinical trials data listed on ClinicalTrials.gov and refresh our database daily.
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Primary study objective is to test the accuracy of the Genius 2 tympanic thermometer and the Exergen TAT-5000(TM) temporal artery thermometer as compared with serial perioperative core temperature measurements obtained in cardiac surgical patients during cardiopulmonary bypass. Study hypothesis: The Genius 2 thermometer will display greater precision and accuracy than the Exergen TAT-5000 thermometer when compared to core body temperature in patients undergoing CABG surgery.
Rationale for Study Oral mucositis is a major complication arising from contemporary chemoradiation treatment of patients with head and neck cancer. No effective therapy exists to prevent this complication in this population. MRX-1024 is an investigational agent that has demonstrated in in vitro and in vivo experiments to have the potential to exert a protective effect in normal mucosa cells, without interfering with the intended antitumor effect of radiation. A ...
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a planned system modification or with a planned system modification. Secondarily, this study aims to compare the influence of baseline variables contributing to the all-cause complication rates for subjects undergoing generator replacement.
The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0 versus current standard of care; and to evaluate performance metrics of the PEAK PlasmaBlade 4.0 during abdominoplasty.
The purpose for the trial is intended to evaluate safety and effectiveness of an oxyhydrogen generator with nebulizer in an adjuvant therapy for patients with severe asthma.
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during lumpectomy; to monitor and record thermal injury depth at the surgical margin and need for additional tissue excision; and to compare these endpoints to the current standard of care.
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care.
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during mastectomy; to monitor and record post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care.
The purpose for this study is to determine safety and effectiveness of the oxyhydrogen generator with nebulizer through an adjuvant therapy for the severe COPD patients in the stable phase.
In many mammals, the duration of the nocturnal melatonin elevation regulates seasonal changes in reproductive hormones such as luteinizing hormone (LH). Melatonin's effects on human reproductive endocrinology are uncertain. It is thought that the same hypothalamic pulse generator may both trigger the pulsatile release of GnRH and LH and also cause hot flashes. Thus, if melatonin suppressed this pulse generator in postmenopausal women, it might moderate hot flashes. This cli...
A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.
This is a phase IV study that will explore the mechanisms of action of a drug (dapagliflozin) that is already commercially available in the country where the study will be conducted (Greece). The drug will be used according to its approved clinical indications (as add-on treatment in patients failed to achieve glycemic targets on metformin monotherapy) and in the approved posology (10 mg/day). Additionally, although there is limited data on the coadministration of dapagliflozin...
A prospective, actively controlled, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA (Treatment Group) as compared to patients treated with conventional open surgery (Control Group).
This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.
Summary of Study Aims To assess, in a randomised fashion: 1. performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire 2. performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire 3. performance of St Jude Pressure Wire versus St Jude Pressure Wire
A randomized controlled trial to evaluate the efficiency of serum tears made with Genius PRP for improving signs and symptoms in Dry Eye Disease (DED). Single center, Prospective, Randomized, Controlled, Non-significant risk
The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to habituate the patient's associated negative emotional reactions to tinnitus, its perception, and ultimately, its impact on the patient's life.
Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.
This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB...
It is increasingly recognised that asthma is not a single disease but that there are many different phenotypes. Much of the work that we have previously carried out has focussed on differentiating children with difficult asthma (those whose asthma control improves with attention to the basics of asthma management such as adherence) from those with severe therapy resistant asthma (ongoing poor control despite high dose treatment and attention to the basics. Our collaborators in ...
The primary aim of this research was to examine the influence of bright light on anxiety in high-anxious young adults. In an acute exposure study, participants were randomly assigned to 45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after the treatments, state anxiety, mood, and blood pressure were assessed. Following the acute exposure study, pa...
This application is to obtain approval for clinical use of the Fenix, a Humanitarian Use Device. The Fenix device was just approved by the FDA as a Humanitarian Exempt Device for fecal incontinence. It has only been utilized in small numbers in Europe. There was a previous device produced by American Medical Systems, who sold their artificial bowel sphincter to Boston Scientific. Boston Scientific has elected to not continue the manufacturing of the artificial bowel sphincter. ...
The objective of the study is to characterize the relationship between select objective metrics and clinical outcomes in chronic pain patients treated with Boston Scientific commercially approved neurostimulation systems.
As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective,...