Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT06524492
Eligibility Criteria:
Inclusion criteria
1. A ventricular CSF shunt with a region of overlying intact skin 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. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision
Exclusion criteria
1. Presence of an interfering open wound or edema in the study device measurement area
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06524492
Study Brief:
Protocol Section:
NCT06524492