Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
Megadott ok: Enrollment
A legfontosabb adatok
- Hol
- Chicago, Evanston, Houston, Orange, Rolling Meadows, Seattle, Tampa és West Hollywood (Egyesült Államok)Mind a 8 helyszín megnézése
Helyszínek itt: Egyesült Államok
- MATTERChicago, Egyesült ÁllamokNo longer taking part
- IndustriousEvanston, Egyesült ÁllamokNo longer taking part
- Texas Medical Center InnovationHouston, Egyesült ÁllamokNo longer taking part
- CHOC Commerce TowerOrange, Egyesült ÁllamokNo longer taking part
- Northwest Special Recreation AssociationRolling Meadows, Egyesült ÁllamokNo longer taking part
- IndustriousSeattle, Egyesült ÁllamokNo longer taking part
- Tampa Marriott Water StreetTampa, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai AcceleratorWest Hollywood, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Rhaeos, Inc.
- Azonosító
- NCT06513572
- A regiszteradat frissítve
- 2025. május 15.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Measurements of Cerebrospinal Fluid Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
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.
Bevonási feltételek: At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device; If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region; Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes); Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes); Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision.
Kizáró feltételek: 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; Patient-reported history of serious adverse skin reactions to silicone-based adhesives; Presence of an interfering open wound or edema in the FlowSense device measurement area; Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study.