Initial Feasibility Study of the CycloPE® Device

This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of the PATH EX CycloPE® device on suspected bacteremia-associated sepsis. All participants are adults diagnosed with suspected bacteremia-associated sepsis, admitted to the intensive care unit (ICU), and meet the inclusion criteria.

NCT Number	NCT06970899
Lead Sponsor	PATH EX, Inc.
Conditions	Sepsis, Infection, Bacteremia Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
Enrollment	15 participants
Start Date	2024-06-11
Primary Completion	2025-04-26 (estimated)
Study Completion	2025-05-15 (estimated)
Updated on ClinicalTrials.gov	2025-05-14