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Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

NCT07361588 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-23

No results posted yet for this 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.

Conditions

  • Targeted Temperature Management

Interventions

DEVICE

Targeted Temperature Management Intranasal Cooling System

VCool Intranasal Cooling System

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • NeuroIntact Inc.

    lead INDUSTRY

Principal Investigators

  • Neeraj Badjatia, MD, MS · University of Maryland

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07361588 on ClinicalTrials.gov