Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study) (POSEIDON)
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|ClinicalTrials.gov Identifier: NCT03973866|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ascites||Device: Alfapump||Not Applicable|
The POSEIDON Study is a multicenter, single arm within subject crossover design pivotal trial conducted in patients diagnosed with refractory or recurrent ascites due to liver cirrhosis who meet inclusion/exclusion criteria. The study will enroll up to 60 pivotal cohort patients with refractory or recurrent ascites at up to 20 sites. In addition, up to 40 additional Roll-in patients will be allowed. An analysis will be conducted to support an application for device approval when a minimum of 40 treated pivotal cohort patients are through 6 months. Patients will be followed for longer-term safety and effectiveness for a total of 2-years post-implant. Patients with a functioning pump at 24 months may consent to continued participation in a long-term follow-up evaluation and with assessments every 6 months from 24 months through the time the pump ceases to function, pump explant or patient death. This long-term follow-up period will continue until the product is approved or the sponsor determines they will no longer pursue product approval.
Pivotal Cohort Patients
Pivotal cohort patients will be evaluated in a 3-month pre-implant observation period during which they will receive standard of care therapy consisting of paracentesis as required for removal of ascitic fluid. Following the initial 3-month observation period during which the number and volume of paracentesis and Quality of life (assessed by general HRQL scores (SF-36)) as well as disease-specific validated questionnaires (Ascites-Q) will be documented, patients will be reevaluated for eligibility for pump implant.
In the study centers without previous experience in pump placement, training in the pump implant procedure will be conducted and up to 3 initial pump implantations conducted as roll-in cases. Roll-in patients will be sequentially enrolled at the site until sufficient experience has been obtained and the site is approved by the sponsor to enroll in the pivotal phase. Roll-in patients will not undergo the 3-month pre-implant observation period and will not be included in the Primary Analysis set but will be summarized separately for purposes of safety evaluation with effectiveness data provided as supplemental. In the event a primary implanter at the site is a replaced or added, up to 3 additional Roll-in implants will be allowed.
All patients (Pivotal and Roll-in) will undergo a final eligibility assessment prior to pump implant. If deemed eligible, patients will be implanted with the alfapump. In the 3 months post-implant, patients will be monitored with pump adjustments as needed to increase or decrease volume of fluid to be removed each day. After this period of stabilization, a 3-month primary endpoint observation period (month 4 through month 6) will begin. In each period, the protocol specifies when symptom driven (therapeutic) paracentesis can be performed per protocol as well as conditions under which the use of diuretics may be considered (all patients must discontinue diuretics post implant procedure).
The study is designed to demonstrate in pivotal cohort patients 1) a 50% reduction (superiority margin) in the per-patient ratio of post-implant 3-month observation period (M4 to M6 post implantation) to pre-implant 3-month observation period with respect to average monthly requirement for therapeutic paracentesis and 2) at least 50% of patients will achieve a 50% reduction in the requirement for therapeutic paracentesis in the same period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alfapump® System in the Treatment of Refractory or Recurrent Ascites: a Multicenter Single Arm Within Subject Crossover Design Pivotal Study (the POSEIDON Study)|
|Actual Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||March 1, 2024|
Implantation of Alfapump
Implantation of alfapump
- Per-patient ratio of post-implant to pre-implant with respect to average monthly number of therapeutic paracentesis [ Time Frame: Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period: ]Defined as removal of ascites ≥1.5L through needle puncture of abdominal wall
- Proportion of patients with at least 50% reduction in number of therapeutic paracenteses from the pre-observation period to post-observation period [ Time Frame: Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period ]Defined as removal of ascites ≥1.5L through needle puncture of abdominal wall
- 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 [ Time Frame: from time of pump implant through 6 months post-implant ]Safety of the alfapump implant procedure and alfapump therapy as determined by rates of explant, reintervention, and other serious device or procedure related adverse events
- Requirement for large volume paracentesis (LVP): change in the average number of LVP events per month (that consist of removing ≥ 5L of ascitic fluid) [ Time Frame: in the post-implant 3-month primary endpoint observation period compared to the pre-implant observation period ]Effectiveness of the alfapump to control ascites as determined by the change in the need for repeated paracentesis compared to baseline
- Change of cumulative volume of ascitic fluid removed by means of therapeutic paracentesis [ Time Frame: in the post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period ]Effectiveness of the alfapump to control ascites as determined by the change in the need for repeated paracentesis compared to baseline
- Change in SF-36 Physical Component Score [ Time Frame: post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period ]The Medical Outcomes Study Short Form Survey Instrument (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal/emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes one item that indicates a perceived change in health. Scoring the SF-36 is a two-step process. First, precoded numeric values are recoded per a scoring key. A high score defines a more favorable health state. Each item is scored on a 0-100 range. The lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scale scores represent the average for all items in the scale that the respondent answered.
- Change in Ascites-Q Score [ Time Frame: in the post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period ]The Ascites-Q was developed by modifying the Polycystic Liver Disease Questionnaire. It includes 11 out of 16 original questions, covering symptoms of abdominal fullness, anorexia, early satiety, nausea, abdominal pain, back pain, dyspnea, reduced mobility, fatigue, insomnia, discomfort because of abdomen size, and problems with sexual intimacy. One other ascites-specific symptom (insomnia) was added. Each individual symptom is assessed with a frequency (6-point Likert scale "never" to "always") and discomfort (5-point Likert scale "not at all" to "a lot") question. Severity scores of individual symptoms are the sum of the frequency and discomfort score (range 2-11). A higher score represents a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973866
|Contact: Jeroen Capel, MScfirstname.lastname@example.org|
|Principal Investigator:||Florence Wong, MD||Toronto General Hospital|