International Alfapump Cohort Study (TOPMOST)

November 8, 2024 updated by: Sequana Medical N.V.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • All patients implanted with an alfapump are eligible for this registry

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months post-implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess occurrence of (major) reportable events.
Time Frame: 2 years
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.
2 years
To assess safety at 1-month post implant for procedure related incidents.
Time Frame: 1 month post implant
o Occurrence of adverse events considered related to implant, product or therapy by the treating physician
1 month post implant
Clinical impact on liver and renal function in liver & renal blood lab panel
Time Frame: 2 years
Clinical impact as assessed by changes in Prealbumin
2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Time Frame: 2 years
Clinical impact as assessed by changes in Albumin.
2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Time Frame: 2 years
Clinical impact as assessed by changes in eGFR.
2 years
Clinical impact on liver and renal function in liver & renal blood lab panel
Time Frame: 2 years
Clinical impact as assessed by changes in createnine.
2 years
Impact of the alfapump on ascites symptoms related quality of life
Time Frame: 2 years
Ascites Questionnaire (pre implant & at each visit after the first month post implant)
2 years
Impact of the alfapump on ascites symptoms related quality of life
Time Frame: 2 years
SF-36 (pre implant at each visit after the first month post implant)
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
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
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
Assess change in physical activity pre- and post implant To assess and evaluate sleep of patients for up to 48 weeks following implant
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

Assess change in physical activity pre- and post implant

  1. To assess daily activity and stress level of patients for up to 48 weeks following implant
  2. To assess and evaluate sleep of patients for up to 48 weeks following implant
  3. To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness
  4. To assess objective stress and inflammation parameters
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
Assess change in physical activity pre- and post implant To assess patient's abdominal pain/discomfort, appetite, satiety, and tiredness
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
Assess change in physical activity pre- and post implant To assess objective stress and inflammation parameters
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
change in ECOG performance scale pre- and post implant
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sequana Medical N.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea De Gottardi, MD, Insel Gruppe AG, University Hospital Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-AAR-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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