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NCT03511339

Pro-2-Cool Device Clinical Study

Completed NA Last updated 3 May 2023
What this trial tests

NA trial testing TecTraum device in Mild Traumatic Brain Injury in 174 participants. Completed in 29 May 2022.

Timeline
4 November 2017
Primary endpoint
27 April 2022
29 May 2022

Quick facts

Lead sponsorTecTraum Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment174
Start date4 November 2017
Primary completion27 April 2022
Estimated completion29 May 2022
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

TecTraum Inc.

Who can join

Adults 12 to 21, any sex, with Mild Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Reduced Concussion Symptom Burden in Early Adolescent Athletes Using a Head-Neck Cooling Device.
    Smith MA, McNinch NL, Chaney D, Shauver L, et al · · 2024 · cited 4× · PMID 38180057 · DOI 10.1097/jsm.0000000000001198

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Other recruiting trials for Mild Traumatic Brain Injury

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03511339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing