A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites

Completed · Not applicable

Conditions studied: Cirrhosis, Ascites

In brief

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.

Key facts

Study ID

NCT02400164

Run by

Sequana Medical N.V.

People needed

30

Starts

2015-03-01

Expected to finish

2018-03-31

Last updated by the study team

2018-04-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients ≥ 21 years of age
• recurrence of grade 3 ascites requiring paracentesis for symptom relief more frequently than once per month for a minimum of 2 of the prior 3 months
• cirrhosis of any etiology
• failure to respond to or intolerance to high dose diuretics
• expected survival of greater than 3 months (MELD score ≤ 21)
• screened for varices and on optimal management
• diagnostic paracentesis with neutrophil count < 250 / µl within 24 hours of implantation
• written informed consent
• ability to comply with study procedures and ability to operate the device
• women of childbearing potential should use adequate contraception

You may not qualify if…

• more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months
• presence of any current cancer
• evidence of extensive ascites loculation
• serum creatinine > 1.5 mg/dl
• serum bilirubin > 5 mg/dl
• eGFR < 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method
• gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study
• hepatic encephalopathy > stage II in the two weeks prior to implant
• presence of a patent TIPS or surgical portosystemic shunt
• presence of Budd-Chiari syndrome
• previous solid organ transplant
• obstructive uropathy (bladder residual volume > 100ml (determined by catheterization or abdominal ultrasound) or any bladder anomaly which may contraindicate implantation of the alfapump, including recurrent urinary tract infections, vesicoureteral reflux, or history of urinary calculi)
• International Prostate Symptom Score (I-PSS) ≥20
• thrombocytopenia < 45,000 X106/l
• patient undergoing therapeutic anticoagulation
• recent (<4 months) intra-abdominal foreign body or abdominal surgery, diaphragmatic hernia, abdominal surgery, severe abdominal adhesions, surgically irreparable hernia, abdominal wall or skin infection, or severe malnutrition.
• history (>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis.
• any non-liver disease with life expectancy < 1 year
• patients eligible for TIPS (unless they have refused TIPS placement).
• presence of any active implantable or body-worn devices that cannot be removed
• pregnancy
• patients being in another therapeutic clinical study

Where it is running

• California Pacific Medical — San Francisco, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Baylor University Healthcare System — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• VCU Medical Centre — Richmond, Virginia, United States
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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