AscitesPOSEIDONNCT03973866
Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)
A study testing Alfapump in people with Ascites, run by Sequana Medical N.V. at 15 sites in 2 countries.
Trial summary
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites
- What is being tested?
- Alfapump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 16 Sep 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of Initial Screening:
- Patients > 18 years of age
- Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
- Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis . Patients must have a minimum of 2 therapeutic paracenteses in the 30 Days prior to enrollment
- Not a candidate for (e.g. refused, contraindicated) Transjugular intrahepatic portosystemic shunt (TIPS) or previously implanted TIPS is permanently obstructed or non-functioning.
- Screened for esophageal varices and on optimal management
Show all 12Show fewer
- Absence of contraindications to prophylactic antibiotic use from time of pump implant
- Life expectancy of at least 6 months following pump implant (approximately 10 months from enrollment)
- Capable of giving written informed consent, willing to comply with study procedures including the 3-month pre-implant observation period and ability to operate and charge the device.
- Women of childbearing age should use adequate contraceptives.
- Reassessed at time of implant procedure (Pivotal Cohort Only):
- Has required a minimum of 5 therapeutic paracenteses in the 3-month observation period prior to pump implant
Who cannot join
- At the time of Initial Screening:
- Renal failure defined as serum creatinine higher than 1.5 mg/dL
- More than one episode of spontaneous bacterial peritonitis over the previous 6 months
- More than one episode of bacterascites over the previous 6 months
- Recurrent urinary infections as per standard criteria, defined as 2 or more episodes over the last 6 months
- Evidence of loculated ascites, as per imaging
Show all 34Show fewer
- Hepatocellular carcinoma, exceeding Milan criteria or for which RF ablation is anticipated
- Pregnant females or females anticipating pregnancy during study period
- Patients currently enrolled in another interventional clinical study that has not reached the primary endpoint assessment point, or (for pivotal cohort) patients who have previously had an alfapump implanted
- Immuno-modulatory treatment (including azathioprine, methotrexate, anti-TNF therapies) used within last 4 months (corticosteroids at stable dose over the last 4 months but < 15 mg/day, or in tapering doses are allowed)
- Known or suspected hepatic or extra hepatic malignancy (other than skin cancer and in-situ cancers), unless adequately treated or in complete remission for ≥ 3 years
- History of bladder cancer
- BMI>40 presenting a risk for technical difficulties for surgery or catheter implantation
- Contraindications to general anesthesia
- Comorbid condition or other reason (example hypertension) that may preclude stopping diuretics after enrollment
- MELD-Na Score > 20
- Budd Chiari syndrome (Pivotal cohort only)
- Clostridium difficile infection within the past year
- Assessed or re-assessed at time of pump implant:
- Acute gastrointestinal hemorrhage requiring transfusions over the previous 42 days
- Condition that prevents continued cessation of diuretic use
- Patient condition does not allow the implant procedure to be performed within the limits of acceptable risk (e.g. cardiovascular comorbidities, variceal bleeding within the previous 6 weeks, skin infections or skin ulcers of the anterior abdominal wall within 2 weeks of device placement)
- Hepatocellular carcinoma exceeding Milan criteria or for which RF ablation is anticipated
- ICU admission since enrollment in the 30 days preceding pump implant procedure
- INR >/= 2.0
- Platelet count of < 50,000 /μL at the time of implantation, unless the platelet count is ≥30,000 / μL and bleeding risk can be satisfactorily addressed with means such as platelet infusion during the implant procedure and/or thrombopoietin receptor agonists
- Bacterial peritonitis within 4 weeks of implant procedure (this includes peritonitis diagnosed at the time of intervention)
- Bacterascites within 4 weeks of implant procedure (this includes bacterascites diagnosed at the time of intervention). Note: at the time of final eligibility (just prior to implantation) the subject will not be allowed to move forward with the procedure if he/she has experienced an episode bacterascites within four weeks of the implant procedure date.
- Serum sodium <125 mmol/L
- Urinary infection within the last 2 weeks
- Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device
- Evidence of renal failure, defined as serum creatinine higher than or equal to 1.5 mg/dL, in the preceding 30 days
- Evidence of loculated ascites, as per imaging
- Pregnant females or females anticipating pregnancy during study period
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Methodist Dallas
Dallas, Texas, 75203
Baylor University Medical Center (Dallas)
Dallas, Texas, 75246
Duke University
Durham, North Carolina, 27705
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, 90048
Medical College of Wisconsin (Froedtert)
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic (Arizona)
Phoenix, Arizona, 85054
McGuire VA Medical Center
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Avera Medical Group
Sioux Falls, South Dakota, 57105
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Canada2 sites
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Toronto General Hospital
Toronto, Ontario
About this study
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)
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation phase after enrollment, followed by implantation of the alfapump and 24 months of post-implant follow up. 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.
Read the detailed description
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 70 pivotal cohort patients with refractory or recurrent ascites at up to 20 sites. In addition, up to 45 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 3 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.
Roll-in Patients
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.
- Conditions
- Ascites
- Being tested
- Alfapump
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfapumpDevice
Implantation of alfapump
| Study group | Role | What they receive |
|---|---|---|
| Alfapump | Experimental | Implantation of Alfapump Receives: Device: Alfapump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-patient ratio of post-implant to pre-implant with respect to average monthly number of therapeutic paracentesis
Defined as removal of ascites ≥1.5L through needle puncture of abdominal wall
Measured: Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period:
Proportion of patients with at least 50% reduction in number of therapeutic paracenteses from the pre-observation period to post-observation period
Defined as removal of ascites ≥1.5L through needle puncture of abdominal wall
Measured: Comparing data from the post-implant 3-month observation period to data from the pre-implant 3-month observation period
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
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
Measured: from time of pump implant through 6 months post-implant
Secondary outcomes (4)
Requirement for large volume paracentesis (LVP): change in the average number of LVP events per month (that consist of removing ≥ 5L of ascitic fluid)
Effectiveness of the alfapump to control ascites as determined by the change in the need for repeated paracentesis compared to baseline
Measured: in the post-implant 3-month primary endpoint observation period compared to the pre-implant observation period
Change of cumulative volume of ascitic fluid removed by means of therapeutic paracentesis
Effectiveness of the alfapump to control ascites as determined by the change in the need for repeated paracentesis compared to baseline
Measured: in the post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period
Change in SF-36 Physical Component Score
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.
Measured: post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period
Change in Ascites-Q Score
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.
Measured: in the post-implant 3-month primary endpoint observation period as compared to the pre-implant 3-month observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start16 Sep 2019
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florence Wong, MD, Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973866
- Sponsor's protocol ID
- 2017-AAR-010
- Acronym
- POSEIDON
- Status last verified
- Nov 2022
- First submitted
- 31 May 2019
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wong F, Vagas HE, Reddy KR, Pagadala MR, Pocha C, Sundaram V, Bajaj JS, Shlomovitz E, Bendel E, Capel J, Kamath PS; POSEIDON Study Group. The Effects of Alfapump on Ascites Control and Quality of Life in Patients With Cirrhosis and Recurrent or Refractory Ascites. Am J Gastroenterol. 2025 Oct 1;120(10):2291-2301. doi: 10.14309/ajg.0000000000003300. Epub 2025 Jan 6.
PubMed 39760647
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03973866
- Acronym / sponsor ID
- POSEIDON / 2017-AAR-010
- Conditions
- Ascites
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The POSEIDON study is a multi-center, prospective, single arm, crossover pivotal study enrolling up to 70 pivotal cohort patients and up to 45 additional Roll-in patients with refractory or recurrent ascites at up to 20 sites. Pivotal cohort patients will undergo a 3-month pre-implant observation phase after enrollment, followed by implantation of the alfapump and 24 months of post-implant follow up. 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.
Detailed description
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 70 pivotal cohort patients with refractory or recurrent ascites at up to 20 sites. In addition, up to 45 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 3 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.
Roll-in Patients
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alfapump | Experimental | Device: AlfapumpImplantation of Alfapump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients > 18 years of age
- Cirrhosis of the liver defined by histological and/or clinical, endoscopic, laboratory and radiological criteria.
- Refractory or recurrent ascites primarily managed with periodic therapeutic paracentesis . Patients must have a minimum of 2 therapeutic paracenteses in the 30 Days prior to enrollment
- Not a candidate for (e.g. refused, contraindicated) Transjugular intrahepatic portosystemic shunt (TIPS) or previously implanted TIPS is permanently obstructed or non-functioning.
- Screened for esophageal varices and on optimal management
Key exclusion criteria (34 listed)
- Renal failure defined as serum creatinine higher than 1.5 mg/dL
- More than one episode of spontaneous bacterial peritonitis over the previous 6 months
- More than one episode of bacterascites over the previous 6 months
- Recurrent urinary infections as per standard criteria, defined as 2 or more episodes over the last 6 months
- Evidence of loculated ascites, as per imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfapumpImplantation of alfapump | Device | Alfapump |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 39760647Wong F, Vagas HE, Reddy KR, Pagadala MR, Pocha C, Sundaram V, Bajaj JS, Shlomovitz E, Bendel E, Capel J, Kamath PS; POSEIDON Study Group. The Effects of Alfapump on Ascites Control and Quality of Life in Patients With Cirrhosis and Recurrent or Refractory Ascites. Am J Gastroenterol. 2025 Oct 1;120(10):2291-2301. doi: 10.14309/ajg.0000000000003300. Epub 2025 Jan 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Wong, MD principal investigator
Toronto General Hospital
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfapump in people with Ascites, run by Sequana Medical N.V. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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:). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.