Your session is about to expire
← Back to Search
Device
Alfapump for Ascites (POSEIDON Trial)
N/A
Waitlist Available
Led By Florence Wong, MD
Research Sponsored by Sequana Medical N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
Patients > 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period
Awards & highlights
POSEIDON Trial Summary
This trial is testing a new device to help people with ascites, a buildup of fluid in the abdomen. The device is implanted and then removed after 24 months.
Who is the study for?
Adults with liver cirrhosis and refractory or recurrent ascites not suitable for TIPS, who've had multiple fluid removal procedures. They must be able to consent, follow study rules, operate the device, have a life expectancy of at least 6 months post-implant, and women must use contraception.Check my eligibility
What is being tested?
The Alfapump System is being tested in patients with hard-to-treat ascites. Participants will be observed for three months before implantation and followed up for two years after receiving the pump to evaluate its effectiveness and safety.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with surgical implantation such as infection, bleeding, device malfunction or complications related to managing ascites.
POSEIDON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cirrhosis of the liver.
Select...
I am older than 18 years.
Select...
I have had at least 2 procedures to remove excess fluid from my abdomen in the last month.
Select...
I cannot have or my TIPS procedure did not work.
Select...
I have been checked for enlarged veins in my esophagus and am managing them.
Select...
I have been diagnosed with cirrhosis of the liver.
Select...
I cannot have or my TIPS procedure did not work.
Select...
I've had at least 5 fluid removal procedures from my abdomen in the last 3 months.
Select...
I can use preventive antibiotics without any health risks.
POSEIDON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined rate of open surgical reintervention due to pump system related adverse event or to restore pump functionality, pump explant due to pump system related adverse event, or pump system related death
Per-patient ratio of post-implant to pre-implant with respect to average monthly number of therapeutic paracentesis
Proportion of patients with at least 50% reduction in number of therapeutic paracenteses from the pre-observation period to post-observation period
Secondary outcome measures
Change in Ascites-Q Score
Change in SF-36 Physical Component Score
Change of cumulative volume of ascitic fluid removed by means of therapeutic paracentesis
+1 morePOSEIDON Trial Design
1Treatment groups
Experimental Treatment
Group I: AlfapumpExperimental Treatment1 Intervention
Implantation of Alfapump
Find a Location
Who is running the clinical trial?
Sequana Medical N.V.Lead Sponsor
15 Previous Clinical Trials
714 Total Patients Enrolled
7 Trials studying Ascites
617 Patients Enrolled for Ascites
Florence Wong, MDPrincipal InvestigatorToronto General Hospital
2 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no other cancers, or they've been in remission for 3+ years.I have been diagnosed with cirrhosis of the liver.I have had a urinary infection in the past 2 weeks.I have had bladder cancer in the past.My kidney function is impaired with creatinine over 1.5 mg/dL.I have had more than one bacterial infection in my abdomen in the last 6 months.My liver cancer is beyond early stage or needs RF ablation treatment.I have had 2 or more urinary infections in the last 6 months.I haven't taken immune-modifying drugs in the last 4 months, except for low-dose or tapering steroids.I had a Clostridium difficile infection in the last year.I am older than 18 years.I have had at least 2 procedures to remove excess fluid from my abdomen in the last month.I cannot have or my TIPS procedure did not work.I have been checked for enlarged veins in my esophagus and am managing them.I have been diagnosed with cirrhosis of the liver.I have had more than one bacterial infection in my abdomen in the last 6 months.My liver cancer is beyond early stage treatment guidelines.My BMI is over 40, which may complicate surgery or catheter placement.I have had a severe stomach or intestine bleed needing blood transfusions in the last 42 days.I have not had bacterial peritonitis in the last 4 weeks.My kidney function is impaired, with creatinine levels at or above 1.5 mg/dL recently.I cannot have general anesthesia due to health reasons.I have not had an infection in my abdominal fluid within the last 4 weeks.I cannot have or my TIPS procedure did not work.I have Budd Chiari syndrome.I cannot stop taking my water pills due to my health condition.I do not have any bladder issues that would prevent device implantation.I've had at least 5 fluid removal procedures from my abdomen in the last 3 months.I can use preventive antibiotics without any health risks.My platelet count is low, but manageable for safe implantation.
Research Study Groups:
This trial has the following groups:- Group 1: Alfapump
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any volunteers being sought to participate in this examination?
"According to clinicaltrials.gov, this particular study is not currently recruiting participants and the last update was made back in November of 2022. However, there are 33 other trials which are actively seeking out enrollees at this moment."
Answered by AI
How many hospitals are currently administering this research project?
"The Toronto General Hospital in Toronto, Ontario; the Hospital of the University of Pennsylvania in Philadelphia, PA and Duke University in Durham, NC are just a few among 21 different trial sites that are currently enrolling patients."
Answered by AI
What objective is this research attempting to accomplish?
"The primary outcome of this medical trial, as specified by the research sponsor Sequana Medical N.V., is per-patient ratio of post-implant to pre-implant regarding average monthly therapeutic paracentesis over a 3-month observation period timeframe. Additionally, secondary outcomes will include change in SF-36 Physical Component Score, transformation in cumulative volume of ascitic fluid eliminated via therapeutic paracentesis and requirement for large volume paracentesis (LVP): alteration concerning the average number of LVP events every month (removing ≥ 5L of ascites)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger