NCT03511339

Pro-2-Cool Device Clinical Study

Pro-2-Cool Device Clinical Study: an Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: TecTraum Inc. · Industry
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.

Detailed description

This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study. Subjects will be assigned to study arm based on a block randomization schedule generated a priori. The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	TecTraum device	A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.

Timeline

• Start date: 2017-11-04
• Primary completion: 2022-04-27
• Completion: 2022-05-29
• First posted: 2018-04-27
• Last updated: 2023-05-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study