Seastar Medical Holding Corporation ((ICU)) announced an update on their ongoing clinical study.
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Seastar Medical Holding Corporation is conducting a pivotal study titled ‘A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy.’ The study aims to evaluate whether the Selective Cytopheretic Device (SCD) can improve survival rates and reduce dialysis duration in patients with Acute Kidney Injury (AKI) who require continuous kidney replacement therapy (CKRT). Approximately 200 participants will be enrolled across 30 sites in the United States.
The intervention being tested is the Selective Cytopheretic Device, which is designed to modulate inflammation by binding activated leukocytes. The device is used in conjunction with the standard CKRT therapy, aiming to enhance treatment outcomes for AKI patients.
This study follows a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. Participants are randomly allocated to either receive the SCD alongside CKRT or CKRT alone, which serves as the standard of care.
The study began on February 24, 2023, with its primary completion and estimated completion dates not yet disclosed. The latest update was submitted on October 22, 2025, indicating ongoing recruitment and progress.
The outcome of this study could significantly influence Seastar Medical’s market position, potentially boosting stock performance if results show improved patient outcomes. The study’s progress is crucial for investors, as successful results could set Seastar Medical apart in the competitive medical device industry.
The study is currently recruiting, with further details available on the ClinicalTrials portal.