Clinical trial NCT02400164: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Ascites
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. patients ≥ 21 years of age
2. 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
3. cirrhosis of any etiology
4. failure to respond to or intolerance to high dose diuretics
5. expected survival of greater than 3 months (MELD score ≤ 21)
6. screened for varices and on optimal management
7. diagnostic paracentesis with neutrophil count \< 250 / µl within 24 hours of implantation
8. written informed consent
9. ability to comply with study procedures and ability to operate the device
10. women of childbearing potential should use adequate contraception

Exclusion Criteria:

1. more than 2 systemic or local infections, such as peritonitis, urinary tract infection, or abdominal skin infection within the last 6 months
2. presence of any current cancer
3. evidence of extensive ascites loculation
4. serum creatinine \> 1.5 mg/dl
5. serum bilirubin \> 5 mg/dl
6. eGFR \< 30 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) method
7. gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to inclusion in the study
8. hepatic encephalopathy \> stage II in the two weeks prior to implant
9. presence of a patent TIPS or surgical portosystemic shunt
10. presence of Budd-Chiari syndrome
11. previous solid organ transplant
12. 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)
13. International Prostate Symptom Score (I-PSS) ≥20
14. thrombocytopenia \< 45,000 X106/l
15. patient undergoing therapeutic anticoagulation
16. 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.
17. history (\>6 months) of diaphragmatic hernia, history of bladder cancer, inflammatory or ischemic bowel disease, and frequent episodes of diverticulitis.
18. any non-liver disease with life expectancy \< 1 year
19. patients eligible for TIPS (unless they have refused TIPS placement).
20. presence of any active implantable or body-worn devices that cannot be removed
21. pregnancy
22. patients being in another therapeutic clinical study

Primary outcomes:
measure: Incidence and severity of serious adverse events related to the device and its implantation.
timeFrame: 12 months
Secondary outcomes:
measure: Assess the overall requirement for large volume paracentesis
timeFrame: 12 months
measure: Nutritional status
timeFrame: 12 months
measure: Evaluate patient quality of life
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Dallas
country: United States
facility: Baylor University Healthcare System
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Centre
state: Virginia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Patrick Kamath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong F, Bendel E, Sniderman K, Frederick T, Haskal ZJ, Sanyal A, Asrani SK, Capel J, Kamath PS. Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump. Liver Transpl. 2020 May;26(5):651-661. doi: 10.1002/lt.25724. Epub 2020 Mar 22.