RECRUITING

Formative Usability Assessment of Wireless Thermal Anisotropy Devices

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

Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.

Official Title

Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts

Quick Facts

Study Start:2023-09-29

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06040697

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:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device 2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 3. Subject or caregiver can clearly communicate and document information in English 4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision 5. Subject is at least 5 years old but not more than 80 years old	1. Presence of an interfering open wound in the device application region 2. Subject-reported history of adverse skin reactions to adhesives

Inclusion Criteria

Exclusion Criteria

1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject or caregiver can clearly communicate and document information in English
4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
5. Subject is at least 5 years old but not more than 80 years old

1. Presence of an interfering open wound in the device application region
2. Subject-reported history of adverse skin reactions to adhesives

Contacts and Locations

Study Contact

Anna Somera

CONTACT

855-814-3569

info@rhaeos.com

Study Locations (Sites)

Rhaeos, Inc.

Chicago, Illinois, 60654

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 Date2023-09-29

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-09-29

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Hydrocephalus