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

NCT03506893 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Ascites
  • Paracentesis
  • Cirrhosis

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.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Marie-Noelle HILLERET, MD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2025-03-25
Completion
2027-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03506893 on ClinicalTrials.gov