Pro-2-Cool Pivotal Trial II
ConditionConcussion, Mild
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-21
SponsorTecTraum Inc.
About this trial
This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.
Eligibility criteria
Qualifiers
Males and females, 13-21 years of age
Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury
Loss of consciousness greater than 30 minutes
Post-traumatic amnesia lasting over 24 hours
Disqualifiers
Age < 13 years or > 21 years
Inability to understand the study requirements or provide informed consent
Cleared to return to play during initial visit
Prior participation in a Pro2Cool Clinical Study
Trial design
Treatments tested in this trial
- Pro2Cool Device
- Sham Cooling Garment Device
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov