Medtronic recently announced it has enrolled its first European patients in its NAVIGATE clinical trial. The international trial will enroll a total of 2,500 patients to assessment the long-term outcomes of the company’s superDimension navigation system as an aid in the early diagnosis and treatment of lung cancer.
The navigation system uses the patented LungGPS technology, the first to allow Electromagnetic Navigation Bronchoscopy (ENB) procedures — a specific procedure that allows a minimally invasive approach to access areas of the lungs that are difficultto reach, eventually aiding in the diagnoses of lung cancer and preventing surgery in cases of benign disease. ENB also replaces more invasive procedures such as transthoracic needle aspiration.
“Early detection, diagnosis, and intervention are crucial to the survival of people living with lung cancer,” Mag. Petra Lichtenberger said in a press release; Lichtenberger is assistant to Prof. Dr. Lamprecht, who enrolled the first patient in Europe at Austria’s Kepler University Clinic Linz Department of Pulmonology. “Technology that allows medical professionals to view areas of the lung that could not be accessed before is a major advance that is changing the landscape of lung cancer diagnosis and helping save patient lives.”
The NAVIGATE clinical trial, a single-arm, multi-center, post-market observational study designed to assess the effects of ENB procedure on early lung cancer diagnosis and treatment, will involve 75 centers worldwide. The study will analyze physicians’ success rate in using the technology to retrieve biopsy samples from the surrounding lymph nodes. The efficiency of physicians’ placement of fiducial markers or dyes to guide succeeding procedures to remove or treat lung tumors will also be assessed.
Since the first trial facility was launched in April 2015, more than 22 sites have opened to enroll patients in the United States. The trial’s healthcare professionals will follow patients for two years.
“The NAVIGATE study represents our commitment to delivering meaningful solutions that support the early detection and treatment of lung cancer to save patient lives,” said Vafa Jamali, president of Early Technologies Business at Medtronic’s Minimally Invasive Therapies Group. “The enrollment of patients in Europe for the NAVIGATE study is a significant milestone and an important step to help establish ENB procedures as the gold standard for detecting lung cancer in the earlier, more curable stages.”
The company also announced that the superDimension system has been granted 510(k) clearance in the U.S. and CE Mark in Europe, as well as approval for a series of other international markets.