Pro-2-Cool Pivotal Trial II

NCT06929923 | Suspended FDA Device

• 1 other identifier: 1380718
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.

Conditions

Mild Traumatic Brain Injury

Keywords

Non-invasive hypothermic therapy

Outcome Measures

Primary Outcomes (1)

• SCAT-5 change from baseline to the post-72 hour follow-up visit measurement

  Sport Concussion Assessment Tool 5th edition (SCAT-5) is the current standard of practice assessment tool used at the time of injury to diagnose an mTBI.

  Baseline to 72-hour follow-up

Study Arms (2)

Pro-2-Cool Device

EXPERIMENTAL

Device: Pro-2-Cool Device

Standard of Care

NO INTERVENTION

"Brain rest"

Interventions

Pro-2-Cool Device DEVICE

The Pro-2-Cool Device is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. Water and isopropyl alcohol cooled to 6°C by the chiller assembly circulate through the cooling garment to create conductive heat transfer from the scalp and carotid arteries, thus achieving cooling of the brain.

Pro-2-Cool Device

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females ages 12 - 21 years
• Initial provider visit is within 8 days of mTBI injury
• Confirmed mTBI diagnosis from sporting activities
• In generally good health as confirmed by medical history and as determined by site investigator
• Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
• Has informed consent obtained per protocol and as required per IRB

You may not qualify if:

• Cleared to return to play during initial visit
• Suffers a serious TBI as evidenced by worsening symptoms, specifically:
• GCS \<14 2.2. Seizure 2.3. Hospitalization 2.4. Existing positive diagnostic testing which include radiology scans that indicate brain bleed 2.5. Slurred speech, which has not resolved within 72 hours of mTBI injury
• Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
• History of a serious medical or psychiatric disorder that include:
• Suicide attempt in the last 6 months 4.2. Unmanaged depression or anxiety 4.3. Hospitalization in the last 6 months for psychiatric treatment
• History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
• Previously diagnosed with a cerebrovascular disorder
• Is unable to understand the study requirements or the informed consent
• Currently enrolled in another investigational research study that may confound the results of this study
• Non-English speaking subjects and parents/legal guardians

Sponsors & Collaborators

• TecTraum Inc.: lead

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Brian Reilly, MD

  Children's Hospital Medical Center of Akron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 16, 2025
• Study Start: February 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)