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Initial Feasibility Study of the CycloPE® Device | Clinical Trials | Clareo Health

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Initial Feasibility Study of the CycloPE® Device

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

NCT06970899•PATH EX, Inc.

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Body temperature \> 101°F (38.3°C) or \< 96.8°F (36°C);
•2. Heart rate \> 90 beats per minute;
•3. Respiratory rate \> 20 breaths per minute;
•4. White blood cell count \> 12,000/mm³, \< 4,000/mm³, or \> 10% bands 4. Clinical evidence of new organ dysfunction 5. Procalcitonin (PCT) levels ≥ 0.5 ng/mL

Exclusion Criteria

•This exclusion criterion is not applicable for two cases:
•1. IV antibiotic treatment initiated \> 48 hours before baseline screening has been deemed ineffective based on the clinical judgment of the investigator.
•2. If the patient has discontinued IV antibiotic therapy for a continuous period of 24 hours or more within the 48-hour window immediately preceding baseline screening.
•11\. Participated in an interventional clinical study within 28 days prior to Day 0 or undergoing treatment anticipated to require significant blood draws 12. Have been previously enrolled in this clinical trial 13. History of or known hypercoagulable state 14. Known history of a condition that may result in an increased risk for thrombosis 15. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment 16. Unable to obtain informed consent from either patient or legally authorized representative 17. Patients who cannot tolerate placement of double-lumen catheter 18. Suspected or confirmed SARS-CoV-2 infection (COVID-19) that cannot be resolved before administration of investigational device.

Locations (1)

Erebuni Medical Cener

Yerevan, Armenia, Armenia

Key Dates

Start Date

June 11, 2024

Primary Completion Date

April 26, 2025

Completion Date

May 15, 2025

Last Updated

May 14, 2025

Enrollment

ACTUAL participants

Conditions

SepsisInfectionBacteremia SepsisSystemic Inflammatory Response Syndrome (SIRS)

Interventions

PATH EX CycloPE® Device

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Initial Feasibility Study of the CycloPE® Device

Inclusion Criteria

Exclusion Criteria

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