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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 Trials | Clareo Health

COMPLETEDNA

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•Sequana Medical N.V.

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
+12 more criteria

Locations (6)

California Pacific Medical

San Francisco, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Baylor University Healthcare System

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

VCU Medical Centre

Richmond, Virginia, United States

Toronto General Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

March 1, 2015

Primary Completion Date

January 19, 2018

Completion Date

March 31, 2018

Last Updated

April 6, 2018

Enrollment

ACTUAL participants

Conditions

CirrhosisAscites

Interventions

alfapump system

DEVICE

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

NCT05597488

Cirrhosis Portal

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RECRUITINGNA

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

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Cirrhosis

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RECRUITING

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Mechanism of TIPS to Improve Sarcopenia

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation