Clinical Trials in the USA / NCT07361588
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Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
NCT07361588 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Targeted Temperature Management
Investigational drug(s) / intervention(s)
Targeted Temperature Management Intranasal Cooling System
Targeted Temperature Management Intranasal Cooling System: VCool Intranasal Cooling System
Study summary
The objective of this study is to evaluate the performance and safety of the VCool Intranasal Cooling System in healthy adult volunteers. The study is designed to gather preliminary data regarding air flow rates and time required to reduce core body temperature to 35.5℃ and maintain the temperature between 35℃ and 36℃ for one hour after cooling.
Eligibility
Inclusion Criteria:
1. Male or female ages 18 to 55.
2. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
3. Baseline core body temperature between 36.8℃ and 37.5℃.
4. Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
5. In the opinion of the Investigator, are able to participate in the study.
Exclusion Criteria:
1. History of cardiovascular, respiratory, or metabolic disorder
2. Any contraindication to undergoing Magnetic Resonance Imaging (MRI)
3. Pregnant
4. Severe peripheral vascular disease
5. History of Raynaud's disease
6. Currently experiencing a respiratory infection
7. Chronic rhinosinusitis
8. History of sickle cell disease
9. History of cold agglutinin disease
10. History of cryoglobulinemia
11. Known deviated septum or nasal deformity
12. History of nosebleeds or a nosebleed within past 24 hours
13. Use of antipyretics or other medications affecting body temperature within the past 24 hours.
Primary outcome measure(s)
- lower core body temperature — 1 hour
To confirm the VCool System can lower core body temperature to 35.5℃. - maintain a core body temperature — 1 hour
To confirm the VCool System can maintain a core body temperature between 35℃ and 36℃ for one hour after cooling. - differential between core body and brain temperature — 2 hours
To evaluate the differential between core body and brain temperature while using VCool.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| R Adams Cowley Shock Trauma Center | Baltimore | Maryland |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07361588 on ClinicalTrials.gov ↗ ← All trials in the USA