BridgeMD
New treatment option for Ascites
Official title Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients
ClinicalTrials.gov ID: NCT03506893
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.
- Patient with an estimated life expectancy of at least 6 months on the day of inclusion.
- Patient with contraindication to the application of a TIPS or who has expressed a refusal of the procedure or a non-functional TIPS
- Patient affiliated with or in receipt of social security
- Informed and written consent signed by the patient.
You likely can't join if
- Local or systemic infection in the month preceding the procedure
- Hepatocellular carcinoma with palliative care
- MELD Score \> 18
- Child Pugh C Score \> 10
- Creatinine Clearance \< 50 ml/mn
- Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion
See the full eligibility criteria
- Patient with refractory ascites who has had a minimum of 5 paracentesis in the last 3 months.
- Patient with an estimated life expectancy of at least 6 months on the day of inclusion.
- Patient with contraindication to the application of a TIPS or who has expressed a refusal of the procedure or a non-functional TIPS
- Patient affiliated with or in receipt of social security
- Informed and written consent signed by the patient.
- Local or systemic infection in the month preceding the procedure
- Hepatocellular carcinoma with palliative care
- MELD Score \> 18
- Child Pugh C Score \> 10
- Creatinine Clearance \< 50 ml/mn
- Digestive hemorrhage or episode of hepatic encephalopathy within two weeks prior to device insertion
- Contraindication to general anesthesia
- Contraindication to implant surgery of the device:
- Obstructive urological impairment
- Partitioning of ascites
- Coagulopathy
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision...
- Patient currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Bordeaux, France
- Clichy, France
- Grenoble, France
- Paris, France
- Poitiers, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Bordeaux, France; Clichy, France; Grenoble, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.