Initial Feasibility Study of the CycloPE® Device

NCT06970899 | Active Not Recruiting FDA Device

• 1 other identifier: QMS-CIP-101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events (SAEs) related to the investigational device

  The incidence and nature of serious adverse events (SAEs) that are related to the use of the PATH EX CycloPE® device will be assessed to evaluate the safety of the investigational device.

  7 days

Secondary Outcomes (6)

• Serious Adverse Events (SAEs) not related to the investigational device or procedure

  7 days

• Clinically significant changes in hematology indices

  7 days

• Clinically significant changes in chemistry indices

  7 days

• Device deficiencies and malfunctions

  7 days

• Clinical and laboratory adverse events (AEs)

  7 days

Study Arms (1)

PATH EX CycloPE® Device

EXPERIMENTAL

Treated with PATH EX CycloPE® Device

Device: PATH EX CycloPE® Device

Interventions

PATH EX CycloPE® Device 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.

PATH EX CycloPE® Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body temperature \> 101°F (38.3°C) or \< 96.8°F (36°C);
• Heart rate \> 90 beats per minute;
• Respiratory rate \> 20 breaths per minute;
• 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

You may not qualify if:

• IV antibiotic treatment initiated \> 48 hours before baseline screening has been deemed ineffective based on the clinical judgment of the investigator.
• 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.
• \. 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.

Sponsors & Collaborators

• PATH EX, Inc.: lead

Study Sites (1)

Erebuni Medical Cener

Yerevan, Armenia, 0087, Armenia

Location

MeSH Terms

Conditions

Sepsis; Infections; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Harutyun N Mangoyan, MD. PhD

  Erebuni Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: June 11, 2024
• Primary Completion: April 26, 2025
• Study Completion: May 15, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)