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Pro-2-Cool Pivotal Trial II

NCT06929923 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

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 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.

Sponsors & Collaborators

  • TecTraum Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Reilly, MD · Children's Hospital Medical Center of Akron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929923 on ClinicalTrials.gov