Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

NCT07361588 | Not Yet Recruiting FDA Device

• 2 other identifiers: 00080424M6785424C6544
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

targeted temperature management

Outcome Measures

Primary Outcomes (3)

• lower core body temperature

  To confirm the VCool System can lower core body temperature to 35.5℃.

  1 hour

• maintain a core body temperature

  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

  To evaluate the differential between core body and brain temperature while using VCool.

  2 hours

Secondary Outcomes (1)

• Bedside Shivering Assessment Scale (BSAS).

  2 hours

Study Arms (1)

Healthy adult volunteers

EXPERIMENTAL

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

Interventions

Targeted Temperature Management Intranasal Cooling System DEVICE

VCool Intranasal Cooling System

Healthy adult volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female ages 18 to 55.
• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Baseline core body temperature between 36.8℃ and 37.5℃.
• Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
• In the opinion of the Investigator, are able to participate in the study.

You may not qualify if:

• History of cardiovascular, respiratory, or metabolic disorder
• Any contraindication to undergoing Magnetic Resonance Imaging (MRI)
• Pregnant
• Severe peripheral vascular disease
• History of Raynaud's disease
• Currently experiencing a respiratory infection
• Chronic rhinosinusitis
• History of sickle cell disease
• History of cold agglutinin disease
• History of cryoglobulinemia
• Known deviated septum or nasal deformity
• History of nosebleeds or a nosebleed within past 24 hours
• Use of antipyretics or other medications affecting body temperature within the past 24 hours.

Sponsors & Collaborators

• NeuroIntact Inc.: lead
• United States Department of Defense: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Neeraj Badjatia, MD, MS

  University of Maryland

  STUDY CHAIR

Central Study Contacts

Bryan Wand, MEng

CONTACT

443-822-9482; bwand@neurointact.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Engineering

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)