CRT ShuntCheck "Fit & Function" Study
CRT ShuntCheck "Fit & Function" Exploratory Study
Studienübersicht
Detaillierte Beschreibung
An exploratory "Fit & Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in CSF shunt flow in hydrocephalus patients. This study will gather information to refine the design of the CRT ShuntCheck sensor. Our Aim I product work will yield a clinic-ready prototype which adheres well to human skin, conforms to the curve surface of the clavicle and provides a safe level of skin cooling over an extended period of time. Many of the clinical uses of CRT will involve patient movement - standing up to investigate suspected overdrainage, or the simple fidgeting of children undergoing monitoring. The Aim II Fit and Function testing will most importantly identify movement-related product performance issues. If we can identify the causes of "signal noise", we can modify our sensor design to make it less susceptible to "motion artifacts".
Additionally testing will identify age/size specific issues - is the sensor small enough for use on younger children, does the looser skin of older adults generate move motion artifacts in the signal.
These studies will include 10 pediatric and 10 adult asymptomatic patients who are willing to undergo CRT ShuntCheck testing over a one hour period. Test results will not be used to guide patient care and testing will not interfere with or delay any other patient testing or care.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21215
- Rekrutierung
- LifeBridge Health, Sinai Hospital of Baltimore (Testing Adult Patients 35 years+)
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Kontakt:
- Michael A Williams, MD
- Telefonnummer: 410-601-1900
- E-Mail: michwill@lifebridgehealth.org
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Hauptermittler:
- Michael A Williams, MD
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Baltimore, Maryland, Vereinigte Staaten, 21287
- Rekrutierung
- Johns Hopkins Hospital (Testing Pediatric Patients Age 3 to 19)
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Kontakt:
- George I Jallo, MD
- Telefonnummer: 410-955-7851
- E-Mail: gjallo1@jhmi.edu
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Hauptermittler:
- George I Jallo, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- For the pediatric subjects, males or females, older than three and less than 20 years of age.
- For the adult subjects, males or females, older than 35 years of age
- Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
- Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
Exclusion Criteria:
- Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
- Study testing would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
- Presence of an interfering open wound or edema over the shunt.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: Fit & function test
CRT ShuntCheck sensors will be applied over the shunts of asymptomatic hydrocephalus patients.
The device will be activated, cooling the skin under the sensor.
Patients will change positions during the one hour procedure and data will be recorded.
Data will be analyzed offline to identify product performance issues due to motion.
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Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sensor fit & function
Zeitfenster: Single visit one hour test procedure
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Fit and Function testing will quantify the level and the duration of thermal changes due to patient movement compared with the level and duration of thermal changes due to changes in shunt flow.
If motion related changes are > 0.5 times the level of flow related changes, the sensor and/or the procedure will be modified to improve signal to noise to >2.0
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Single visit one hour test procedure
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Identify any safety issues
Zeitfenster: Single visit one hour test
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The CRT ShuntCheck test is a non-invasive, non-significant risk procedure.
A small area of skin at the clavicle is cooled to and held at room temperature for an extended period of time.
Study subjects should experience zero significant adverse events and no temperature related adverse events beyond minor discomfort.
Any EA's will be addressed in design modifications.
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Single visit one hour test
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NDxDev-CRT-2015
- R44NS074486 (US NIH Stipendium/Vertrag)
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