Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ascites
- Cirrhosis
- Paracentesis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Refractory ascites is one of the complications associated with portal hypertension in the cirrhotic patient. To date, its treatment consists of evacuating punctures, performed in day hospitalisation, whose frequency is adapted to the rate of ascites synthetis. Paracentesis, which does not affect the...
Refractory ascites is one of the complications associated with portal hypertension in the cirrhotic patient. To date, its treatment consists of evacuating punctures, performed in day hospitalisation, whose frequency is adapted to the rate of ascites synthetis. Paracentesis, which does not affect the mechanisms of ascites formation, contributes to protein catabolism and undernutrition. They also have an inconvenience linked to the gesture, making frequent hospital stays necessary. For all these reasons, the patient's quality of life is diminished. The Alfapump® system is a new method for the treatment of refractory ascites. It is a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder, where ascites is eliminated by urinary tract.
Tracking Information
- NCT #
- NCT03506893
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marie-Noelle HILLERET, MD University Hospital, Grenoble
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