Back to resultsA (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)
Primary Purpose
Cirrhosis, Ascites
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
alfapump system
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis
Eligibility Criteria
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
Sites / Locations
- California Pacific Medical
- Mayo Clinic
- Baylor University Healthcare System
- University of Virginia
- VCU Medical Centre
- Toronto General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
alfapump system
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence and severity of serious adverse events related to the device and its implantation.
Secondary Outcome Measures
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
Nutritional status
Nutritional status
o evaluate changes in serum prealbumin
Evaluate patient quality of life
Evaluate patient quality of life
chronic liver disease questionnaire (CLDQ)
PLD questionnaire
ECOG performance status
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02400164
Brief 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
Acronym
MOSAIC
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sequana Medical N.V.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Ascites
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alfapump system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
alfapump system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence and severity of serious adverse events related to the device and its implantation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assess the overall requirement for large volume paracentesis
Description
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
Time Frame
12 months
Title
Nutritional status
Description
Nutritional status
o evaluate changes in serum prealbumin
Time Frame
12 months
Title
Evaluate patient quality of life
Description
Evaluate patient quality of life
chronic liver disease questionnaire (CLDQ)
PLD questionnaire
ECOG performance status
Time Frame
12 months
Title
Overall survival
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Kamath, MD
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Medical
City
San Francisco
State/Province
California
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Baylor University Healthcare System
City
Dallas
State/Province
Texas
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
VCU Medical Centre
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
31999044
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.
Results Reference
derived
Learn more about this trial
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
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