Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
NeuroIntact Inc.
Study ID
NCT07361588
Status
Not Yet Recruiting

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Conditions

  • Targeted Temperature Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Targeted Temperature Management Intranasal Cooling System — DEVICE
    VCool Intranasal Cooling System

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.

Primary Outcome Measure

lower core body temperature [ Time Frame: 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201
Neeraj Badjatia, MD, MS
410.328.4515

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