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Clinical trials
catalyst calendar across sponsors →Studies where SEQUA.BR is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
10 interventional · 4 observational
government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| International Alfapump Cohort StudyNCT04326946observationalPatient survival at 6 months post implant | — | Active, not recruiting | Device: Alfapump | Liver Cirrhoses, Malignant Ascites | 400 | 2028-12-31 | in 865 d | 2024-11-12 |
| Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)NCT03973866Per-patient ratio of post-implant to pre-implant with respect to average monthly number of therapeutic paracentesisOpen-label · Treatment | Not applicable | Active, not recruiting | Device: Alfapump | Ascites | 110 | 2024-03-30 | — | 2022-12-01 |
| Management of Volume Overload HF Patients by Individual DSR Treatment adJustment-a clinicAl inVestigation of InfusatE2.0NCT05965934Adverse event rate through end of treatment periodRandomized · Open-label · Treatment | Phase 1/2 | Unknown status | Drug: Direct Sodium Removal Infusate 2.0 | Heart Failure, Volume Overload | 33 | 2024-12-31 | — | 2023-07-28 |
| Safety & Feasibility of DSR TherApy in Heart FAiluRe pAtients With Persistent CongestionNCT04882358Safety - Treatment related SAERandomized · Open-label · Other | Not applicable | Unknown status | Device: ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM · Drug: SGLT2 inhibitor | Heart Failure, Volume Overload | 24 | 2022-08-31actual | — | 2022-11-09 |
| Malignant Ascites Alfapump® StudyNCT04076566observationalMonthly therapeutic paracentesis frequency up to 3 months | — | Withdrawnsponsor's stated reason: Update to clinical strategy - COVID impact | Device: alfapump system | Malignant Ascites | 0 | Dec 2021 | — | 2020-08-10 |
| Alfapump Direct Sodium Removal (DSR) Feasibility StudyNCT04116034Safety in-hospital - Device relatedOpen-label · Device feasibility | Not applicable | Completed | Device: alfapump DSR system | Heart Failure, Congestive Heart Failure, Cardiorenal Syndrome, Volume Overload, Sodium Excess, Sodium Disorder | 8 | 2021-04-15actual | — | 2021-05-28 |
| Optimal Balance Alfapump® System Feasibility StudyNCT03032211Occurrence of adverse events (AEs) and serious adverse events (SAEs)Open-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Change in company strategy | Device: Alfapump | Heart Failure | 0 | 2020-12-31 | — | 2021-03-22 |
| ALFApump System Post Marketing Surveillance RegistryNCT01532427observationalSafety | — | Completed | — | Liver Cirrhosis, Refractory Ascites, Malignant Ascites | 100 | 2019-07-08actual | — | 2020-10-26 |
| Retrospective Study in the Use of the Alfapump and the Treatment of Malignant AscitesNCT03200106observationalChange in frequency of LVP after implantation of the alfapump | — | Completed | Device: Alfapump | Malignant Ascites | 17 | 2018-02-28actual | — | 2018-04-09 |
| A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent AscitesNCT02400164Incidence and severity of serious adverse events related to the device and its implantation.Open-label · Treatment | Not applicable | Completed | Device: alfapump system | Cirrhosis, Ascites | 30 | 2018-01-19actual | — | 2018-04-06 |
| Alfapump-albumin Replacement TherapyNCT02448160To assess whether intermittent human albumin replacement in accordance with large volume paracentesis guidelines (8g/L ascites drained) can prevent the development of renal dysfunction, measured by serum creatinineOpen-label · Treatment | Not applicable | Terminatedsponsor's stated reason: Recruitment problems | Device: alfapump · Drug: salt-poor Human Albumin solution | Liver Cirrhosis | 10 | Dec 2017actual | — | 2018-04-09 |
| Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory FunctionNCT01438970The main aim of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites.Open-label · Treatment | Phase 2 | Unknown status | Device: ALFApump system | Cirrhosis, Liver, Refractory Ascites | 12 | Dec 2016 | — | 2016-08-11 |
| Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.NCT01952327Incidence and severity of device, procedure and therapy related serious adverse events.Open-label · Treatment | Not applicable | Terminated | Device: The pleurapump system | Pleural Effusion | 2 | 2016-12-13actual | — | 2017-06-14 |
| ALFApump System Versus Standard of Care in Ascites TreatmentNCT01528410Paracentesis free survivalRandomized · Open-label · Treatment | Phase 3 | Completed | Device: ALFApump removal of ascites · Procedure: Large volume paracentesis for removal of ascites | Refractory or Recurrent Ascites | 58 | 2016-09-21actual | — | 2017-06-14 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19