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
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-000994
- Rochester, Minnesota: 15-000994
NCT ID: NCT02400164
Sponsor Protocol Number: 2013-AAR-007
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- ≥ 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
- Has had 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
- Eligible for TIPS (unless they have refused TIPS placement)
- Presence of any active implantable or body-worn devices that cannot be removed
- Pregnancy
- Being in another therapeutic clinical study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Patrick Kamath, M.D. |
Closed for enrollment |
|
Rochester, Minn.
Mayo Clinic principal investigator Patrick Kamath, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available