Targeted Temperature ManagementNCT07361588
Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
A study testing Targeted Temperature Management Intranasal Cooling System in people with Targeted Temperature Management, run by NeuroIntact Inc. at 1 site in United States.
Trial 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℃… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Targeted Temperature Management
- What is being tested?
- Targeted Temperature Management Intranasal Cooling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Neeraj Badjatia, MD, MS, 410.328.4515, nbadjatia@som.umaryland.edu
About this study
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
- Being tested
- Targeted Temperature Management Intranasal Cooling System
- Keywords
- targeted temperature management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Temperature Management Intranasal Cooling SystemDevice
VCool Intranasal Cooling System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Targeted Temperature Management Intranasal Cooling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower core body temperature
To confirm the VCool System can lower core body temperature to 35.5℃.
Measured: 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.
Measured: 1 hour
differential between core body and brain temperature
To evaluate the differential between core body and brain temperature while using VCool.
Measured: 2 hours
Secondary outcomes (1)
Bedside Shivering Assessment Scale (BSAS).
To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Targeted Temperature ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroIntact Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, United States Department of Defense
- Responsible party
- Principal investigator, Bryan Wand, NeuroIntact Inc.
- Investigators
- Neeraj Badjatia, MD, MS, Study chair, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361588
- Sponsor's protocol ID
- 00080424
- Other IDs
- M6785424C6544
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07361588
- Acronym / sponsor ID
- 00080424
- Conditions
- Targeted Temperature Management
- Keywords
- targeted temperature management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NeuroIntact Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore, United States Department of Defense
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult volunteers | Experimental | Device: Targeted Temperature Management Intranasal Cooling SystemThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Temperature Management Intranasal Cooling SystemVCool Intranasal Cooling System | Device | Healthy adult volunteers |
Primary outcome
lower core body temperature
Time frame: 1 hour
To confirm the VCool System can lower core body temperature to 35.5℃.
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.
differential between core body and brain temperature
Time frame: 2 hours
To evaluate the differential between core body and brain temperature while using VCool.
1 secondary outcome
Bedside Shivering Assessment Scale (BSAS).
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neeraj Badjatia, MD, MS study chair
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Temperature Management Intranasal Cooling System in people with Targeted Temperature Management, run by NeuroIntact Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Wand, MEng (443-822-9482, bwand@neurointact.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower core body temperature (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.