Tusker Medical, Inc, a Menlo Park, CA-based medical device company for ENT surgeons, announced the enrollment of the first in-office patients in the OTTER Study, a clinical study for Tusker’s Tubes Under Local Anesthesia (TULA) System. Via an approved Investigational Device Exemption (IDE), the OTTER Study will evaluate the in-office placement of tympanostomy tubes in approximately 300 children ages 6 months through 12 years old enrolled at up to 25 investigational sites in the United States and Canada, according to Tusker’s announcement.
Tympanostomy tube insertion is reportedly the most common ambulatory pediatric surgery in the United States,1 performed to treat recurrent ear infections or persistent fluid in the middle ear.
“Tubes are very effective for pediatric patients, but must be inserted in the operating room under general anesthesia,” said Larry Lustig, MD, principal investigator and chair of the Department of Otolaryngology-Head & Neck Surgery at the Columbia University Medical Center in New York City. “This is often quite concerning for parents of small children, can be stressful for the child, requires pre-procedure fasting, and time off after the procedure. While general anesthesia for tube procedures is considered quite safe, there is an emerging body of research suggesting that there may be longer-term neurodevelopmental risks associated with pediatric general anesthesia. The OTTER Study will investigate a new device/drug combination product designed to enable in-office tube procedures in pediatric patients, avoiding the risks of general anesthesia.”
The TULA technology consists of an Iontophoresis System, a local anesthetic, and a Tube Delivery System. In combination with the local anesthetic, the Iontophoresis System is designed to provide safe, reliable, and child-friendly bilateral local anesthesia of the tympanic membrane, enabling a viable alternative to general anesthesia.
“The Tusker Iontophoresis System uses a small amount of electrical current to accelerate the uptake of the local anesthetic into the tympanic membrane,” said Amir Abolfathi, president and CEO of Tusker Medical. “This provides an alternative to phenol (a denaturing acid), ear canal injections, or other local anesthesia methods, none of which have FDA approval for pediatric tympanic membrane anesthesia and are often painful or take an unacceptably long time to achieve anesthesia.”
Once the tympanic membrane is numb, the Tube Delivery System is used to insert the tympanostomy tube. With a single button push, the Tube Delivery System automatically creates the myringotomy and reportedly inserts the tube in less than 500 milliseconds. The myringotomy cutter is exposed only for the very brief moment when the myringotomy is created, and is otherwise recessed within the device, an important safety feature when performing procedures in an awake child. Parents are present during the TULA office-based procedure, and younger children may sit on their parent’s lap, if desired.
Sedatives or anxiolytics such as midazolam or nitrous oxide are not permitted in the OTTER study.
“Most ENT surgeons are unfamiliar with or uncomfortable administering respiratory depressants in their office setting,” said Sujana Chandrasekhar, MD, past-president of the American Academy of Otolaryngology-Head and Neck Surgery and Tusker Medical Scientific Advisor. “The goal of the TULA technology is to provide an option for in-office pediatric tube placement that is acceptable and accessible to the broad otolaryngology community and their patients.”
Ototoxicity, pharmacokinetic, and adult clinical study results for the Tusker technology were submitted to FDA to assess the TULA System prior to initiation of the OTTER Study.
1. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol-Head Neck Surg. 2013;149(1S): S1-S35.
Source: Tusker Medical, Otolaryngology–Head and Neck Surgery