Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

Last updated: May 12, 2025
Sponsor: Rhaeos, Inc.
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

FlowSense

Clinical Study ID

NCT06513572
2024-03
  • All Genders

Study Summary

This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. At least one existing ventricular CSF shunt, functional or non-functional (includingan adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheterdisconnection or fracture, distal catheter fragment left in place during shuntsurgery, or indication that the shunt is otherwise non-functional), with a region ofoverlying intact skin appropriate in size for application of the study device

  2. If more than one distal shunt catheter is present, at least one distal shuntcatheter is at least 2 cm away from any other distal shunt catheter in the devicemeasurement region

  3. Signed informed consent by subject or a parent, legal guardian, health care agent,or surrogate decision maker (according to local statutes)

  4. Signed medical records release by subject or a parent, legal guardian, health careagent, or surrogate decision maker (according to local statutes)

  5. Verbal assent by minors 7 years of age and older who are able to understand thestudy and communicate their decision

Exclusion

Exclusion criteria:

  1. Presence of an interfering open wound or edema in the FlowSense device measurementarea

  2. Patient-reported history of serious adverse skin reactions to silicone-basedadhesives

  3. Use of the study device would interfere with standard patient care, or emergencysurgery that cannot be delayed, or participation in the study will interfere with,or be detrimental to, administration of optimal healthcare to the subject

  4. Participation in any other investigational procedural, pharmaceutical, and/or devicestudy that may influence the collection of valid data under this study

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: FlowSense
Phase:
Study Start date:
July 25, 2024
Estimated Completion Date:
July 27, 2024

Connect with a study center

  • CHOC Commerce Tower

    Orange, California 92868
    United States

    Site Not Available

  • Cedars-Sinai Accelerator

    West Hollywood, California 90048
    United States

    Site Not Available

  • Tampa Marriott Water Street

    Tampa, Florida 33602
    United States

    Site Not Available

  • MATTER

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Industrious

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Northwest Special Recreation Association

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Texas Medical Center Innovation

    Houston, Texas 77021
    United States

    Site Not Available

  • Industrious

    Seattle, Washington 98015
    United States

    Site Not Available

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