RECRUITING

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Official Title

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

Quick Facts

Study Start:2023-11-17

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06086561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters) 2. Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device 3. Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home) 4. Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting) 5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English 7. Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision 8. Patient is at least 5 years old but not more than 80 years old	1. Presence of an interfering open wound or edema over any portion of the shunt 2. Patient-reported history of adverse skin reactions to adhesives 3. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable 4. Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home) 5. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance 6. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject 7. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Inclusion Criteria

Exclusion Criteria

1. At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
2. Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
3. Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)
4. Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
7. Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision
8. Patient is at least 5 years old but not more than 80 years old

1. Presence of an interfering open wound or edema over any portion of the shunt
2. Patient-reported history of adverse skin reactions to adhesives
3. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
4. Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)
5. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
6. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
7. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Contacts and Locations

Study Contact

Anna Somera

CONTACT

855-814-3569

info@rhaeos.com

Study Locations (Sites)

Tampa Marriott Water Street

Tampa, Florida, 33602

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

United States

MATTER

Chicago, Illinois, 60611

United States

Northwest Special Recreation Association

Rolling Meadows, Illinois, 60008

United States

Collaborators and Investigators

Sponsor: Rhaeos, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17

Study Completion Date2025-04

Study Record Updates

Study Start Date2023-11-17

Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

Hydrocephalus