MULTI-CENTER CLINICAL TRIAL
At TecTraum we believe in science before sales, as evidenced by our current, multi-center clinical trial.
To uncover the overall safety, efficacy, and clinical data of TecTraum’s pro2cool®, we implemented funding for a mass clinical trial to validate the product’s ability to treat concussions. pro2cool® will be hypothermic therapy treatment available for concussions, and we strive to ensure total safety and tolerability for all users.
TecTraum has partnered with one of the nation’s leading pediatric facilities, Akron Children’s Hospital, to serve as the primary investigative site for the trial. The Ohio-based hospital draws in 800,000 patient visits each year from around the world for their pediatric services. Akron Children’s has also earned Best Children’s Hospital rankings by US News & World Report in 6 of the 10 specialties. Since the launch of this multi-year undertaking, Akron has been joined by other top ranking hospital systems, including the University of Michigan, Cincinnati Children’s Hospital and Dayton Children’s Hospital. With the help of Akron Children’s Hospital, our trial seeks to identify the therapeutic benefits of cooling therapy delivered through the pro2cool® system by studying hundreds of high school athletes across Ohio and Michigan.
On average, 1 in 5 high school athletes sustain a sports concussion during the season. To preserve brain health and further the advancement of pro2cool®, we chose young athletes as our participants. Subjects participating in the trial are students and athletes between the ages of 12-21.
There are many benefits to sports including teaching kids about accountability, teamwork, leadership, and many other crucial life skills. A concussion shouldn’t be what holds an athlete back. That’s where pro2cool™ steps in. The company was founded when several professional athletes joined forces with innovative engineers to solve the problem of the lack of treatment for concussions. We understand the problem, and some of our athletes have first-hand experience. The trial candidates will receive optimum care and be a part of a revolutionary time in the medical field.
Sports concussions have been a hot topic in the news for the last decade and parents play a crucial role in the communication between student athletes and their coaches, trainers, and doctors.
Changing the Protocol to pro2cool®
Rest is currently the only way to recover from a concussion. However, what if there’s a way to speed up the healing process? With pro2cool® we look to limit the amount of time injured athletes need to spend in recovery and help be the key to a faster recovery. The current method of resting the brain limits activities such as playing video games, reading, texting, schoolwork, and sports. These activities are a big part of a person’s life, especially with adolescents. At TecTraum, we don’t want those who suffer from concussions to be kept in the dark for so long, and we are anticipating pro2cool™ to be the solution.
Participant Data Collection
Within the clinical trial, both quantitative and qualitative data is collected through examination by a trained healthcare professional who records clinical signs (observed by the healthcare professional) and symptoms (reported by the patient). A standardized scoring system known as the Sports Concussion Assessment Tool (SCAT 5) is implemented as an optimum scoring system for assessment and is necessary to determine the efficacy of the product.
Goals of the Trial
The goal of the trial is to determine if the treatment can help a student-athlete, or accident-inflicted person recover from a concussion. Cooling therapy has been around for hundreds of years and is the standard initial care used to protect the brain in several health emergencies such as cardiac arrest, certain types of heart attacks, and more. Our mission is to add concussions to that list, and our vision is to be the first in the world to develop a safe and effective therapy for the treatment of concussions.
The cooling device is light-weight, portable, and designed to be used in a variety of clinical settings – from the Emergency Room to the doctor’s office and beyond. The user interface is intuitive and can be operated by a variety of healthcare personnel – including a certified athletic trainer. It is designed to be easy to use, and efficient for trainers to treat injured players on and off the field and are trained to recognize concussions under the guidance of a physician.
How the Trial Benefits the Medical Field
There is no clear standard care for concussion and no FDA approved therapy of any kind., This trial can be the breakthrough the medical field has been waiting for. The trial will show us what works, and possibly what doesn’t, and in the end, we’ll have a device that can potentially speed up the recovery of active teens and adults who are injured while doing what they love. Concussions aren’t a disease you can prevent, and they often result from sport-related injuries. However, just because we can’t prevent them, doesn’t mean we shouldn’t strive to heal them. Our trial has set out to do what no other has achieved and be the first in the world to develop a safe and effective therapy for the treatment of concussions.