NCT06970899

Initial Feasibility Study of the CycloPE® Device

Evaluation of the CycloPE® Device Used in Patients With a Suspected Bloodstream Infection

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: PATH EX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-center, prospective, single-arm clinical study designed to evaluate the feasibility, safety, and performance of the PATH EX CycloPE® device for the treatment of suspected bacteremia-associated sepsis in critically ill patients. Participants in the study will be adults diagnosed with suspected bacteremia-associated sepsis, admitted to the intensive care unit (ICU), and meeting all inclusion and exclusion criteria. Each patient will undergo two treatments with the PATH EX CycloPE® device. The second treatment will occur 24-36 hours after the start of the first treatment, with each session lasting 4 hours. Clinical and laboratory assessments will be conducted at baseline and predefined intervals during and after the treatment period to monitor safety and evaluate the device's performance. The primary endpoints focus on feasibility and safety, including device-related adverse events and procedural success. Secondary endpoints will assess infection resolution through microbial eradication, reductions in biomarkers, and changes in hematology and chemistry indices. The PATH EX CycloPE® device is a novel extracorporeal blood filtration system designed to directly target and remove bacteria from the bloodstream. By addressing the root cause of sepsis, the device has the potential to improve outcomes for critically ill patients. This study will generate critical data to inform the design of future clinical trials and support the development of this breakthrough technology for the treatment of sepsis. All data will be collected, analyzed, and reported in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements

Conditions

• Sepsis
• Infection
• Bacteremia Sepsis
• Systemic Inflammatory Response Syndrome (SIRS)

Interventions

Type	Name	Description
DEVICE	PATH EX CycloPE® Device	Participants in this arm will receive two extracorporeal blood filtration treatments using the PATH EX CycloPE® device. The first treatment will be initiated following baseline assessments, and the second treatment will occur 24-36 hours after the start of the first treatment. Each treatment will last up to 4 hours. The device is designed to target and remove bacteria from the bloodstream. All participants will also receive standard-of-care treatment for sepsis, including IV antibiotics, as determined by the treating physician.

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-04-26
• Completion: 2025-05-15
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: Armenia

Regulatory

• FDA-regulated device study