PATH EX CycloPE®
Human Factors Simulated Use Study

PATH EX is focused on bringing its medical device, CycloPE®, to market, offering a solution for patients with sepsis. CycloPE® is an investigational medical device designed to directly capture and remove bacteria from the bloodstream, providing a rapid, targeted solution for sepsis treatment.

PATH EX is interested in conducting a Human Factors Simulated Use Study that will assess how healthcare professionals interact with the device, its labeling, and its Instructions for Use (IFU) under simulated clinical conditions. This study is being conducted to evaluate the usability of the device and associated labeling in support of regulatory submissions to the U.S. Food and Drug Administration (FDA). We are seeking approximately 20 ICU nurses to participate.

Conditions and qualifications of eligible human factors participants include:

  • Must reside and work in Houston, TX, and be currently licensed and practicing as an ICU nurse with experience in extracorporeal therapies (e.g., hemodialysis, CRRT, or similar systems)
  • Must have time to commit for up to 3 hours away from work
  • Must have availability Monday-Friday between May 4-22

Activities, expectations, and your agreement include:

  1. Provide CV/resume for qualification screening
  2. Attend the testing session per our mutually agreed upon scheduled date/time
  3. Consent to participate
  4. Receive standardized training on the CycloPE® device
  5. Participate in a simulated-use session in a controlled environment
  6. With access to instructions for use, perform tasks related to device preparation, setup, and use unaided by the testing personnel
  7. Be observed by test personnel during task performance
  8. Be asked to provide feedback following the session

Participation is voluntary, and you may withdraw at any time. This is a simulated-use study; no patient care will be involved.

Participants who complete the session will receive a $250 Visa gift card.

Location and Dates:

  • Site: 2450 Holcombe Blvd, Houston, TX 77021
  • The session will take approximately 3 hours
  • May 4-22, 2026
  • Morning/evening/lunch hours available for scheduling
Nurse holding a patient's hand in an ICU
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If you’re interested in participating in this research activity, please complete the contact form below. You will be contacted by the CRS study team!

Contact Dulce Mariscal, PhD (du***@************************es.com) to assess your eligibility and schedule preferences.

PATH EX CycloPE® Human Factors Participant Sign-up

PATH EX CycloPE Human Factors Participant Sign-up
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