Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
A legfontosabb adatok
- Hol
- Chicago, Rolling Meadows és Tampa (Egyesült Államok)Mind a 4 helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 5 és 80 év között vagy?
Forrás: NCT06086561: ki vehet részt
Helyszínek itt: Egyesült Államok
- MATTERChicago, Egyesült ÁllamokContact: Anna SomeraRésztvevőt keres
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Egyesült ÁllamokContact: Anna SomeraNo longer taking part
- Northwest Special Recreation AssociationRolling Meadows, Egyesült ÁllamokContact: Anna SomeraRésztvevőt keres
- Tampa Marriott Water StreetTampa, Egyesült ÁllamokContact: Anna SomeraRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Rhaeos, Inc.
- Azonosító
- NCT06086561
- A regiszteradat frissítve
- 2025. május 15.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters); 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; Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home); 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); Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes); Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English; Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision; Patient is at least 5 years old but not more than 80 years old.
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 adverse skin reactions to adhesives; Presence of an interfering open wound or edema over any portion of the shunt; Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable; Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home); Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance; Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study.