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Pro-2-Cool Device Clinical Study

NCT03511339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2023-05-03

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 when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.

Conditions

  • Mild Traumatic Brain Injury

Interventions

DEVICE

TecTraum device

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

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Akron Children's Hospital

    collaborator OTHER

  • TecTraum Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Congeni, MD · Akron Children's Hospital

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
2017-11-04
Primary Completion
2022-04-27
Completion
2022-05-29
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 NCT03511339 on ClinicalTrials.gov