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Active, Not Recruiting

NCT Number: NCT04326946

International Alfapump Cohort Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Cirrhoses Malignant Ascites

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Leipzig, Leipzig, Germany

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alfapump

Device

alfapump implementation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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
    • 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

  12. 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

  13. 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

  14. Clinical impact on ECOG

    Time frame: 2 years

    change in ECOG performance scale pre- and post implant

Sponsors and collaborators

Lead sponsor

Sequana Medical N.V.

Industry

Registry information

Official study 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

Acronym: TOPMOST

Important dates

Study start
2018
Primary completion
2028
Study completion
2030
First posted
Mar 30, 2020
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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