Pro-2-Cool Device Clinical Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03511339|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2018
Last Update Posted : May 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury||Device: TecTraum device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 4, 2017|
|Actual Primary Completion Date :||April 27, 2022|
|Estimated Study Completion Date :||October 2022|
No Intervention: Control
Experimental: TecTraum Device
Treatment with study device
Device: TecTraum device
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
Other Name: Pro-2-Cool
- The SCAT5 overall score will be collected at the initial visit in the Sports Medicine Clinic, and compared to follow-up visits throughout the study, with the objective of demonstrating better outcomes in the treatment group compared to the control group. [ Time Frame: Change from initial visit to 4 weeks ]
Formal statistical hypothesis testing will be employed in the evaluation of this endpoint.
Additionally, comparisons between treatment groups on the baseline SCAT5 (SCAT5-PRE) will be performed at initial visit (as reported by subject) and at each follow-up (72 hours, 10 days, and 4 weeks) separately to evaluate the time trend in recovery. Individual SCAT5 symptoms, each scored on a scale of 0-6, will also be summarized and compared by treatment group to investigate the effect of treatment on specific symptoms. These comparisons are intended to provide additional information on the pattern of recovery and are not attached to intended labeling claims; however, statistical testing of these endpoints will be accompanied by adjustment for multiplicity using the Hochberg-Holm method.
- Recovery time from initial visit, summarized by group and compared in the treatment group to control. [ Time Frame: Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit. ]Recovery time from initial visit will be formally evaluated for differences between treatment and control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511339
|United States, Michigan|
|University of Michigan - Michigan Medicine|
|Ann Arbor, Michigan, United States, 48108|
|United States, Ohio|
|Akron Children's Hospital|
|Akron, Ohio, United States, 44308-1062|
|Akron Children's Hospital, Mahoning Valley Campus|
|Boardman, Ohio, United States, 44512|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Dayton Children's Hospital|
|Dayton, Ohio, United States, 45404|
|Principal Investigator:||Joseph Congeni, MD||Akron Children's Hospital|