Clinical Trial

Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The overall objective of this study is to collect preliminary effectiveness and safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021 and marketing authorization through the FDA De Novo process in September 2023.
Protocol Amendment History 3 changes
notable Enrollment closed, study ongoing 2026-08-15
critical Primary completion pushed: 2026-12-15 -> 2028-05 2026-08-15
minor Completion pushed: 2026-12-15 -> 2028-08 2026-08-15
Trial Details
NCT Number NCT06685848
Lead Sponsor Hemanext
Conditions Hematologic Neoplasms
Enrollment 24 participants
Start Date 2024-11-29
Primary Completion 2028-05 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-14