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A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites (MOSAIC)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
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A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients with Cirrhosis
Rochester, Minn.
This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.
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Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study) (POSEIDON)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The primary purpose of this study is to collect and analze data evaluating the effectiveness of the alfapump to control ascites as determined by the reduction in the need for repeated paracentesis compared to baseline
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Development and Validation of an Ascites-Specific Patient Reported Outcome Questionnaire
Rochester, Minn.
The purpose of this study is to develop and validate a brief patient reported outcomes questionaire that is responsive to ascites-related symptoms in liver cirrhosis.
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Pretest of Alfapump® Patient Preference Discrete-choice Experiment
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The overall objective of the patient preference evaluation is to understand how patients tradeoff the benefits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.
The alfapump system is designed to reduce or eliminate the need for therapeutic paracentesis and to provide relief from symptoms of tense ascites with its attendant effects on patient quality of life (QOL) and nutrition. fits and risks of the alfapump related to the primary endpoints of the current POSEIDON clinical trial in support of future marketing application.
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Technological Innovation: Patient Buddy Mobile Health App to Evaluate the Effectiveness of PROs Elicited to Prevent Unavoidable Readmission, the Improvement in HRQOL and Prevention of Hospitalizations in Patients with Cirrhosis (AHRQ)
Rochester, Minn.
The study plans to follow three groups of cirrhotic patients from the time of hospital dismissal randomly divided into either receiving standard of care, using devices through which they can communicate with the clinical teams and using devices and structured follow-up over thirty days. The study aims to develop these devices so as to learn quickly about issues that patients and their caregivers are facing so that clinicans can intervene to stop unnecessary re-hospitalizations in this population.
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