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

Cirrhosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400164
• Other study ID #: 2013-AAR-007
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: April 5, 2018
• Start date: March 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Sequana Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	University of Virginia	Charlottesville	Virginia
United States	Baylor University Healthcare System	Dallas	Texas
United States	VCU Medical Centre	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	California Pacific Medical	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sequana Medical AG

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of serious adverse events related to the device and its implantation.		12 months
Secondary	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
Secondary	Nutritional status	Nutritional status; o evaluate changes in serum prealbumin	12 months
Secondary	Evaluate patient quality of life	Evaluate patient quality of life; chronic liver disease questionnaire (CLDQ); PLD questionnaire; ECOG performance status	12 months
Secondary	Overall survival		12 months