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 (MOSAIC)

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Ascites
• Intervention / Treatment: Device: alfapump system

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Toronto General Hospital
• United States
  • California
    • San Francisco, California, United States
      • California Pacific Medical
  • Minnesota
    • Rochester, Minnesota, United States
      • Mayo Clinic
  • Texas
    • Dallas, Texas, United States
      • Baylor University Healthcare System
  • Virginia
    • Charlottesville, Virginia, United States
      • University of Virginia
    • Richmond, Virginia, United States
      • VCU Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alfapump system; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Overall survival		12 months
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

Collaborators and Investigators

• Sponsor: Sequana Medical N.V.
• Investigators: Principal Investigator: Patrick Kamath, MD, Mayo Clinic, Rochester, MN

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): January 19, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ascites
• Other Study ID Numbers: 2013-AAR-007