An interventional study of alfapump system in Cirrhosis and Ascites, sponsored by Sequana Medical N.V.. Completed at 6 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Sequana Medical N.V. · Not applicable, Interventional, and Treatment
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.
3,273 studies on the registry are indexed under Fibrosis; 466 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 2,137 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Sequana Medical N.V. is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.
Device: alfapump system
The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.
Incidence and severity of serious adverse events related to the device and its implantation.
Time frame: 12 months
Assess the overall requirement for large volume paracentesis
Assess the overall requirement for large volume paracentesis by investigation of: * the number of large volume therapeutic paracentesis events and all paracentesis events * the annualized rate of large volume therapeutic paracentesis and of all paracentesis events * the cumulative volume of ascites removed through all paracentesis events • Assess the overall requirement for large volume paracentesis by investigation of: * the number of large volume therapeutic paracentesis events and all paracentesis events * the annualized rate of large volume therapeutic paracentesis and of all paracentesis events * the cumulative volume of ascites removed through all paracentesis events
Time frame: 12 months
Nutritional status
Nutritional status o evaluate changes in serum prealbumin
Time frame: 12 months
Evaluate patient quality of life
Evaluate patient quality of life * chronic liver disease questionnaire (CLDQ) * PLD questionnaire * ECOG performance status
Time frame: 12 months
Overall survival
Time frame: 12 months
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Sequana Medical N.V.