Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance (PIONEER)
This study is ongoing, but not recruiting participants.
Sponsor:
NovaShunt AG
Information provided by (Responsible Party):
NovaShunt AG
ClinicalTrials.gov Identifier:
NCT01030185
First received: December 10, 2009
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.
Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.
| Condition | Intervention | Phase |
|---|---|---|
|
Ascites |
Device: NovaShunt's Automated Fluid Shunt implantation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-center, Open Label, Non-randomized Study to Investigate the Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by NovaShunt AG:
Primary Outcome Measures:
- The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Paracentesis requirements [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
- Hematology [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Incidence of hemodynamic instability [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Incidence and severity of peripheral edema [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Patient Quality of Life. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NovaShunt's Automated Fluid Shunt
The Automated Fluid Shunt (AFS) Device
|
Device: NovaShunt's Automated Fluid Shunt implantation
The Automated Fluid Shunt (AFS) Device consists of an implantable sealed housing which contains an internally powered pump with supportive electronic components and circuits, an implantable Peritoneal Catheter, implantable Bladder Catheter and a non-implantable Charger used for wireless recharging an AFS battery and collecting data from the Device.
Other Name: NovaShunt
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients ≥ 18 years of age
- Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis.
- Cirrhosis of any etiology
- Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
- Dietary sodium restriction <88mEq/d.
- Serum creatinine levels of ≤ 2.0 mg/dL for at least 7 days before study entry.
- Total bilirubin levels of less than 3 mg/dL.
- Expected survival of greater than 6 months
- Written informed consent
- Ability to comply with study procedures and ability to operate the device.
- Women of childbearing age should use adequate contraceptives
Exclusion Criteria:
- Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- Presence of peritoneal carcinomatosis
Advanced hepatocellular carcinoma, demonstrated by:
- One tumor that is >5 cm diameter
- 3 or more nodules of >3 cm diameter
- Portal thrombosis
- Other evidence of a malignant Etiology for Ascites
- Evidence of extensive ascites loculation
- Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study.
- Hepatic encephalopathy in the two weeks prior to implant
- Presence of a TIPS or surgical portosystemic shunt
- Presence of Budd-Chiari syndrome
- Previous liver transplant
- Obstructive uropathy
- Coagulopathy that could not be corrected to a prothrombin time INR <1.8,
- Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
- Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
- Any condition requiring emergency treatment
- Pregnancy
- Patients being in another clinical study that did not reach primary endpoint yet
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030185
Locations
| Belgium | |
| Department of hepatology, UZ Leuven, campus Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Bulgaria | |
| Military Medical Academy, Clinica of Gastroenterology and Hepatology | |
| Sofia, Bulgaria, 1606 | |
| Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC | |
| Sofia, Bulgaria, 1404 | |
| Germany | |
| Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum | |
| Berlin, Germany, 13353 | |
| Medizinische Klinik und Poliklinik I | |
| Bonn, Germany, 53105 | |
| Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität | |
| Frankfurt, Germany, 60590 | |
| Universitätsklinikum Regensburg | |
| Regensburg, Germany, 93053 | |
| Spain | |
| Hospital General Uneversitario de Alicante | |
| Alicante, Spain, 03010 | |
| Hospital de la Santa Pau I Sant Creu | |
| Barcelona, Spain, 08025 | |
Sponsors and Collaborators
NovaShunt AG
Investigators
| Principal Investigator: | Jose Such, MD | Hospital General Uneversitario de Alicante C/ Maestro Alonso 109 - 03010 Alicante /Alacant, Spain |
More Information
No publications provided
| Responsible Party: | NovaShunt AG |
| ClinicalTrials.gov Identifier: | NCT01030185 History of Changes |
| Other Study ID Numbers: | 2009-AAR-002 |
| Study First Received: | December 10, 2009 |
| Last Updated: | April 30, 2013 |
| Health Authority: | Spain: Ethics Committee Germany: Ethics Commission |
Keywords provided by NovaShunt AG:
|
ascites liver cirrhosis |
Additional relevant MeSH terms:
|
Ascites Pathologic Processes Diuretics |
Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013