Clinical Trial Compares BeamPath Flexible CO2 Laser Fiber To Pulse Dye Laser
OmniGuide announced that the initial patients have been treated in a clinical study evaluating patient quality of life and airway patency.
The patient's quality of life and airway patency will be measured during the time of treatment, and then at select post-operative intervals for four weeks, as well as during follow up treatments. The patients will be partially treated with the OmniGuide BeamPath system and then partially treated with the Pulse Dye Laser. The treatments will take place on awake patients under a local anesthetic in an outpatient clinic setting.
Patients treated recently with the OmniGuide BeamPath CO2 laser fiber that have previously been treated with the Pulse Dye Laser, report that the BeamPath fiber therapy provided a less frequent recurrence as well as less pain and a faster recovery. This initial study will evaluate and quantify in a standardized protocol these reported outcomes.
Recurrent Respiratory Papillomatosis (RRP) is a chronic disease which affects patients worldwide. Caused by the human papilloma virus (HPV), RRP is a serious disease, which may lead to respiratory failure when the airway is blocked by lesions. The disease may present in childhood (Juvenile Onset Recurrent Respiratory Papillomatosis) or in adulthood (Adult Onset Recurrent Papillomatosis). Respiratory papillomas are the most common benign laryngeal tumors in children, and have a high recurrence rate.
Traditional methods of treatment such as a micro-debrider involve excision of papillomas, as well as anti-viral agents in an operating room setting under general anesthesia. Newer technologies such as the OmniGuide BeamPath flexible CO2 laser fiber have allowed for treating of awake patients in an office or clinic setting, rather than being placed under general anesthesia. Many surgeons are treating more patients in an office setting, rather than in an operating room, and believe that newer technologies such as the OmniGuide flexible CO2 fiber technology will increase the applicability of office treatments.
Stacey L. Halum, M.D., Assistant Professor of Otolaryngology, Indiana University School of Medicine is the primary investigator.