Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

January 21, 2026 updated by: Bryan Wand, NeuroIntact Inc.
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Targeted Temperature Management Intranasal Cooling System
VCool Intranasal Cooling System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower core body temperature
Time Frame: 1 hour
To confirm the VCool System can lower core body temperature to 35.5℃.
1 hour
maintain a core body temperature
Time Frame: 1 hour
To confirm the VCool System can maintain a core body temperature between 35℃ and 36℃ for one hour after cooling.
1 hour
differential between core body and brain temperature
Time Frame: 2 hours
To evaluate the differential between core body and brain temperature while using VCool.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bedside Shivering Assessment Scale (BSAS).
Time Frame: 2 hours
To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroIntact Inc.

Collaborators

University of Maryland, Baltimore
United States Department of Defense

Investigators

  • Study Chair: Neeraj Badjatia, MD, MS, University of Maryland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00080424
  • M6785424C6544 (Other Grant/Funding Number: MARCORSYSCOM- Marine Corps System Command - Department of defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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