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RECRUITING
NCT03506893
NA

Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

Summary

The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2018-07-17

Completion Date

2027-05-31

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

DEVICE

Alphapump

Alfapump® device: a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder where they are eliminated by the urinary tract. Medical device marked CE, used in the indication provided for marking

PROCEDURE

Ascites puncture

Hospitalizations for evacuating ascites are performed at least twice a month and can be up to 2 times a week. A clinical and biological examination is carried out at each visit.

Locations (10)

Amiens-Picardie University Hospital

Amiens, France

Chu Angers

Angers, France

Jean MINJOZ Univesity Hospital

Besançon, France

Haut-Lévêque Hospital

Bordeaux, France

Beaujon Hospital

Clichy, France

Grenoble University Hospital

Grenoble, France

LA PITIE SALPETRIERE Univesity Hospital

Paris, France

Chu Poitiers

Poitiers, France

Chu Pontchaillou

Rennes, France

Toulouse University Hospital

Toulouse, France