PIONEER: Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

• Sponsor: NovaShunt AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01030185
• Collaborator: (none)
• Enrollment: 40
• Locations: 9
• Arm: 1
• Duration (Months): 40
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Ascites	Device: NovaShunt's Automated Fluid Shunt implantation	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

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 Names: NovaShunt

Outcome Measures

Primary Outcome Measures

1. The safety of the NovaShunt AFS will be evaluated by the incidence and severity of device- and procedure-related serious adverse events [6 months]

Secondary Outcome Measures

1. Paracentesis requirements [6 month]

2. Hematology [6 month]

3. Incidence of hemodynamic instability [6 month]

4. Incidence and severity of peripheral edema [6 month]

5. Patient Quality of Life. [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. One tumor that is >5 cm diameter

2. 3 or more nodules of >3 cm diameter

3. 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

Locations

	Site	City	State	Country	Postal Code
1	Department of hepatology, UZ Leuven, campus Gasthuisberg	Leuven		Belgium	3000
2	Clinic of Internal Diseases, MHAT "Tokuda Hospital Sofia" JSC	Sofia		Bulgaria	1404
3	Military Medical Academy, Clinica of Gastroenterology and Hepatology	Sofia		Bulgaria	1606
4	Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Charité, Campus Virchow Klinikum	Berlin		Germany	13353
5	Medizinische Klinik und Poliklinik I	Bonn		Germany	53105
6	Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität	Frankfurt		Germany	60590
7	Universitätsklinikum Regensburg	Regensburg		Germany	93053
8	Hospital General Uneversitario de Alicante	Alicante		Spain	03010
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NovaShunt AG
• ClinicalTrials.gov Identifier: NCT01030185
• Other Study ID Numbers: 2009-AAR-002
• First Posted: Dec 11, 2009
• Last Update Posted: Sep 6, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by NovaShunt AG: ascites; liver cirrhosis
• Additional relevant MeSH terms: Ascites

Study Results

No Results Posted as of Sep 6, 2013