Liver CirrhosesTOPMOSTNCT04326946
International Alfapump Cohort Study
An observational study of Liver Cirrhoses and Malignant Ascites, run by Sequana Medical N.V. at 2 sites in 2 countries.
Trial summary
This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhoses, Malignant Ascites
- What is being tested?
- Alfapump
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Aug 2018to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The TOPMOST will target to include, in a real-world setting, all patients implanted with an alfapump system as per intended use, not participating in another clinical study in which the alfapump is being evaluated.
Who may be able to join
- All patients implanted with an alfapump are eligible for this registry
Who cannot join
- Patients younger than 18 years
- Pregnancy
- Inability to operate the Smart Charger to recharge the alfapump
- Participating in another study in which the alfapump is studied
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: International Alfapump Cohort Study: in Patients With Refractory Ascites Due to Liver Cirrhosis or Malignant Ascites With a Life Expectancy of 6 Months or Less
This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company.
Read the detailed description
In a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.
- Conditions
- Liver Cirrhoses, Malignant Ascites
- Being tested
- Alfapump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfapumpDevice
alfapump implementation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival at 6 months post implant
The primary outcome will be patient survival with a functional alfapump system at 6 months.
Measured: 6 months post-implant
Secondary outcomes (14)
To assess occurrence of (major) reportable events.
Reportable events are defined as any events per the definition in 9.1 and classified as renal event, variceal bleeding, hepatic encephalopathy an infection or assessed as related (not classified "improbable related" or "cannot be attributed" per the definitions below) to; the implant procedure, device or therapy by the treating physician.
Measured: 2 years
To assess safety at 1-month post implant for procedure related incidents.
- Occurrence of adverse events considered related to implant, product or therapy by the treating physician
Measured: 1 month post implant
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in Prealbumin
Measured: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in Albumin.
Measured: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in eGFR.
Measured: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Clinical impact as assessed by changes in createnine.
Measured: 2 years
Impact of the alfapump on ascites symptoms related quality of life
Ascites Questionnaire (pre implant \& at each visit after the first month post implant)
Measured: 2 years
Impact of the alfapump on ascites symptoms related quality of life
SF-36 (pre implant at each visit after the first month post implant)
Measured: 2 years
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Assess change in physical activity pre- and post implant To assess daily activity and stress level of patients for up to 48 weeks following implant
Measured: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Assess change in physical activity pre- and post implant To assess and evaluate sleep of patients for up to 48 weeks following implant
Measured: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Assess change in physical activity pre- and post implant
- To assess daily activity and stress level of patients for up to 48 weeks following implant
- To assess and evaluate sleep of patients for up to 48 weeks following implant
- To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness
- To assess objective stress and inflammation parameters
Measured: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Assess change in physical activity pre- and post implant To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness
Measured: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Assess change in physical activity pre- and post implant To assess objective stress and inflammation parameters
Measured: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Clinical impact on ECOG
change in ECOG performance scale pre- and post implant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start14 Aug 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea De Gottardi, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326946
- Sponsor's protocol ID
- 2019-AAR-012
- Acronym
- TOPMOST
- Status last verified
- Nov 2024
- First submitted
- 25 Jun 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Alfapump Cohort Study: in Patients With Refractory Ascites Due to Liver Cirrhosis or Malignant Ascites With a Life Expectancy of 6 Months or Less
- ClinicalTrials.gov ID
- NCT04326946
- Acronym / sponsor ID
- TOPMOST / 2019-AAR-012
- Conditions
- Liver Cirrhoses, Malignant Ascites
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Mar 2020 (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.
This Registry is designed to follow patients who have been implanted with an alfapump system, which is a newly marketed product from Sequana Medical AG, a Swiss Medical Device company.
Detailed description
In a real-world setting, all patients implanted with an alfapump system according to it's intended use, not participating in another clinical study in which the alfapump is studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The TOPMOST will target to include, in a real-world setting, all patients implanted with an alfapump system as per intended use, not participating in another clinical study in which the alfapump is being evaluated.
Key inclusion criteria (1 listed)
- All patients implanted with an alfapump are eligible for this registry
Key exclusion criteria (4 listed)
- Patients younger than 18 years
- Pregnancy
- Inability to operate the Smart Charger to recharge the alfapump
- Participating in another study in which the alfapump is studied
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 |
|---|---|---|
| Alfapumpalfapump implementation | Device | – |
Primary outcome
Patient survival at 6 months post implant
Time frame: 6 months post-implant
The primary outcome will be patient survival with a functional alfapump system at 6 months.
14 secondary outcomes
To assess occurrence of (major) reportable events.
Time frame: 2 years
To assess safety at 1-month post implant for procedure related incidents.
Time frame: 1 month post implant
Clinical impact on liver and renal function in liver & renal blood lab panel
Time frame: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Time frame: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Time frame: 2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Time frame: 2 years
Impact of the alfapump on ascites symptoms related quality of life
Time frame: 2 years
Impact of the alfapump on ascites symptoms related quality of life
Time frame: 2 years
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Time frame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Time frame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Time frame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Time frame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Impact of the alfapump on ascites symptoms related quality of life on patient activity
Time frame: 1 week pre-implant, Day 0 Implant, 4 weeks-, 8 weeks-, 16 weeks-, 24 weeks- and 48 weeks post implant
Clinical impact on ECOG
Time frame: 2 years
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 12 Nov 2024.
- Individual participant dataSharing planned: Undecided. To be decided
Related trials for Liver Cirrhoses
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruiting
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
Cirrhoses, Liver
RecruitingPhase 4
Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver
Cirrhoses, Liver, Decompensated Cirrhosis of Liver
Not yet recruitingObservational study
Detecting Liver Fibrosis in Patients At-risk
Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease
Active, not recruitingObservational study
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis
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.
Andrea De Gottardi, MD principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhoses and Malignant Ascites, run by Sequana Medical N.V. at 2 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 1 inclusion and 4 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
Patient survival at 6 months post implant (time frame: 6 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.