Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers

NeuroIntact Inc.

Status: Not yet enrolling

Conditions: Targeted Temperature Management

Treatments: Device: Targeted Temperature Management Intranasal Cooling System

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT07361588

00080424

M6785424C6544 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Healthy adult volunteers

Experimental group

Description:

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.

Treatment:

Device: Targeted Temperature Management Intranasal Cooling System