U.S., April 17 -- ClinicalTrials.gov registry received information related to the study (NCT06929923) titled 'Pro-2-Cool Pivotal Trial II' on April 14.
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.
Study Start Date: Feb. 20
Study Type: INTERVENTIONAL
Condition:
Mild Traumatic Brain Injury
Intervention:
DEVICE: Pro-2-Cool 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 6degC by the chiller asse...