Hadassah Hospitals technology transfer company Hadasit and Tel Aviv University technology transfer company Ramot announced today that their jointly developed Lubo Cervical Collar, designed for use in trauma situations, had demonstrated positive results in a two-part Phase I safety study. The IRB approved study was registered with the National Institute of Health (NIH) and operated under the guidelines of both the NIH and the Israeli Ministry of Health.
Trauma is a major killer of people between the ages of five and 40. All injured patients in trauma are at risk for cervical spine instability and air blockage. Though these patients are transported by pre-hospital teams with a cervical collar to protect the cervical spine, existing cervical collars ensure cervical spine stabilization but do not protect the airway of the patient, which is opened by invasive means in necessary situations.
Dr. Omri Lubovsky, developer of the LuboCollar and a physician in the Department of Orthopedic Surgery at Hadassah University Hospital said, “LuboCollar is designed to protect the neck by restricting the movement of the head relative to the rest of the body and to maintain an open airway in a non-invasive, simple and quick to operate way. It does so by using a “jaw-thrust”-like knob to maneuver the mandibles, pushing them forward in the direction of the chin."
The study included twenty people divided into two groups: one awake, and a second under anesthesia during already planned surgeries. No adverse side effects (pressure sores, local irritation or damage) were reported for either group. The evaluations in both the first and second part of the study were conducted immediately after the collar was removed, again two hours later, and for a final review 24 hours post.
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