The company has designed the trial to compare the use of the enlightenVue disposable micro-endoscope with conventional reusable endoscopes
enlightenVue has commenced single-use micro-endoscope study. (Credit: Silas Camargo Silão from Pixabay)
enlightenVue has recruited the first patient in the clinical trial designed to assess the single-use micro-endoscope efficacy in paediatric ear, nose and throat (ENT) applications.
The company already secured 510(k) clearance from the US Food and Drug Administration (FDA) for its single-use micro-endoscope.
The current trial is the first of several planned studies to evaluate the potential advantages of the single-use micro-endoscope’s small (2mm) working diameter with two working channels and improved visualisation capabilities.
enlightenVue has designed the clinical study to compare the use of the enlightenVue disposable micro-endoscope with conventional reusable endoscopes.
enlightenVue co-founder and CEO Dr Giacomo Basadonna said: “The enlightenVue micro-endoscope was designed for applications such as pediatric ENT, where the system’s small size and interventional capability may provide a significant advantage in addition to reduced infection risk.
“This trial, and others we are planning in additional applications, will allow us to demonstrate its value in a variety of medical and surgical applications.”
The company will recruit 30 patients that require the use of a nasopharyngoscope in the trial. The patients will be randomised between the enlightenVue micro-endoscope or a traditional reusable nasopharyngoscope.
As part of the trial, the operating room, emergency departments, neonatal ICU, and hospital step down and floor unit settings will be used.
The trial will assess image quality, ease of obtaining the necessary view, ergonomic aspects patient comfort and cooperation, patient, guardian and clinician satisfaction and use of the working channel for biopsy, suction, and other interventions.
The enlightenVue endoscope is claimed to be the only 2mm single-use endoscope with two working channels and a laser light source currently on the market.
Its working channels allows health care providers to conduct a variety of interventional procedures, thereby enhancing patient’s outcome and reducing the overall cost of treatment.