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

NCT02400164 | Completed

• 1 other identifier: 2013-AAR-007
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 6

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.

Conditions

Cirrhosis; Ascites

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of serious adverse events related to the device and its implantation.

  12 months

Secondary Outcomes (4)

• Assess the overall requirement for large volume paracentesis

  12 months

• Nutritional status

  12 months

• Evaluate patient quality of life

  12 months

• Overall survival

  12 months

Study Arms (1)

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.

Device: alfapump system

Interventions

alfapump system DEVICE

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.

alfapump system

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (6)

California Pacific Medical

San Francisco, California, United States

Location

Mayo Clinic

Rochester, Minnesota, United States

Location

Baylor University Healthcare System

Dallas, Texas, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

VCU Medical Centre

Richmond, Virginia, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Publications (1)

• 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.

  PMID: 31999044 DERIVED

MeSH Terms

Conditions

Fibrosis; Ascites

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Kamath, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: January 19, 2018
• Study Completion: March 31, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

CA (1); US (5)