Effects of Treatment of Ascites by the ALFApump System on... | NCT01438970

Studies
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function

NCT01438970

Sponsor

Sequana Medical N.V.

Status

Unknown status

Last Update Posted

Aug 11, 2016Estimated

Enrollment

12Estimated

Phase

Phase 2

Conditions

Cirrhosis, Liver
Refractory Ascites

Interventions

ALFApump system

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 20, 2011

First Submission Date that Met QC Criteria

Sep 21, 2011

First Posted Date

Sep 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2016

Last Update Posted Date

Aug 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following:

To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up.
To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA.
To determine the incidence of complications associated with treatment in the course of follow-up.
To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALFApump system implantation	Other	Implantation of ALFApump system	Device: ALFApump system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALFApump system	Device	The device described above will be implanted using general anaesthesia. The device will be programmed according to each patient's individual requirements, setting the daily loss of ascitic fluid needed to maintain a stable body weight.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.		One month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > 18 years of age
Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 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:

Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
Serum bilirubin greater than 5 mg/dl.
Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
Clinical evidence of loculated ascites.
Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
Previous liver transplant.
Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
Pregnancy
Patients being in another clinical study that did not reach primary endpoint yet

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008103	Liver Cirrhosis
D001201	Ascites

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes