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Initial Feasibility Study of the CycloPE® Device

NCT06970899 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-05-14

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • PATH EX, Inc.

    lead INDUSTRY

Principal Investigators

  • Harutyun N Mangoyan, MD. PhD · Erebuni Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2025-04-26
Completion
2025-05-15
FDA Device
Yes

Countries

  • Armenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970899 on ClinicalTrials.gov