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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cirrhosis, Ascites

Intervention / Treatment
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* Device: alfapump system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alfapump system<br>The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis. | Device: alfapump system<br>* The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of serious adverse events related to the device and its implantation. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the overall requirement for large volume paracentesis | Assess the overall requirement for large volume paracentesis by investigation of: the number of large volume therapeutic paracentesis events and all paracentesis events the annualized rate of large volume therapeutic paracentesis and of all paracentesis events the cumulative volume of ascites removed through all paracentesis events • Assess the overall requirement for large volume paracentesis by investigation of: the number of large volume therapeutic paracentesis events and all paracentesis events the annualized rate of large volume therapeutic paracentesis and of all paracentesis events the cumulative volume of ascites removed through all paracentesis events | 12 months | 
| Nutritional status | Nutritional status o evaluate changes in serum prealbumin | 12 months | 
| Evaluate patient quality of life | Evaluate patient quality of life chronic liver disease questionnaire (CLDQ) PLD questionnaire ECOG performance status | 12 months | 
| Overall survival |  | 12 months |