Status:
SUSPENDED
Pro-2-Cool Pivotal Trial II
Lead Sponsor:
TecTraum Inc.
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
12-21 years
Phase:
NA
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 yea...
Detailed Description
This is a multi-center, prospective, randomized, non-blinded, dual-arm comparator study enrolling up to a total of 72 patients (approximately 36 patients in the treatment arm and 36 patients in the co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Cleared to return to play during initial visit
- Suffers a serious TBI as evidenced by worsening symptoms, specifically:
- 1. 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:
- 1. 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
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06929923
Start Date
February 20 2025
End Date
February 1 2026
Last Update
July 25 2025
Active Locations (2)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109
2
Akron Children's Hospital
Akron, Ohio, United States, 44308