CirrhosisMOSAICNCT02400164
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
A study testing alfapump system in people with Cirrhosis and Ascites, run by Sequana Medical N.V. at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- alfapump system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2015to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Virginia
Charlottesville, Virginia
Baylor University Healthcare System
Dallas, Texas
VCU Medical Centre
Richmond, Virginia
Mayo Clinic
Rochester, Minnesota
California Pacific Medical
San Francisco, California
About this study
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.
- Being tested
- alfapump system
- Medical subject headings
- Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfapump systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| alfapump system | Experimental | 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. Receives: Device: alfapump system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of serious adverse events related to the device and its implantation.
Measured: 12 months
Secondary outcomes (4)
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
Measured: 12 months
Nutritional status
Nutritional status
- evaluate changes in serum prealbumin
Measured: 12 months
Evaluate patient quality of life
Evaluate patient quality of life
- chronic liver disease questionnaire (CLDQ)
- PLD questionnaire
- ECOG performance status
Measured: 12 months
Overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion19 Jan 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Kamath, MD, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400164
- Sponsor's protocol ID
- 2013-AAR-007
- Acronym
- MOSAIC
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2015
- Last updated
- 6 Apr 2018
- Results posted
- No
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.
PubMed 31999044
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02400164
- Acronym / sponsor ID
- MOSAIC / 2013-AAR-007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alfapump system | Experimental | Device: alfapump systemThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alfapump systemThe 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 |
Primary outcome
Incidence and severity of serious adverse events related to the device and its implantation.
Time frame: 12 months
4 secondary outcomes
Assess the overall requirement for large volume paracentesis
Time frame: 12 months
Nutritional status
Time frame: 12 months
Evaluate patient quality of life
Time frame: 12 months
Overall survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 31999044Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Kamath, MD principal investigator
Mayo Clinic, Rochester, MN
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alfapump system in people with Cirrhosis and Ascites, run by Sequana Medical N.V. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of serious adverse events related to the device and its implantation. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.