INSYTE Trial Begins for Spryte’s Neuro OCT Imaging System for Intracranial Aneurysm Procedures

March 4, 2026—Spryte Medical announced the commencement of enrollment in the INSYTE trial evaluating the company’s neuro-optical CT (nOCT) imaging system.

According to the company, the prospective, single-arm, unblinded, multicenter INSYTE trial will assess the nOCT system’s ability to provide high-quality intravascular images to support diagnostic assessment in the neurovasculature during endovascular intracranial aneurysm treatment and follow-up procedures. The trial will emphasize the safety and imaging performance of the system, noted the company.

The Coprincipal Investigators of the INSYTE trial are neurosurgeons Ricardo Hanel, MD, and Demetrius Lopes, MD. Dr. Hanel is from Baptist Health Jacksonville in Jacksonville, Florida. Dr. Lopes from Advocate Health in Chicago, Illinois.

The first patients in the trial were enrolled at Baptist Health Jacksonville by the neurointerventional team led by Dr. Hanel. Additional clinical sites are expected to initiate enrollment as the trial progresses, advised Spryte Medical.

“Despite advances in endovascular therapy, our ability to visualize the vessel wall and device–tissue interaction during aneurysm treatment remains limited,” commented Dr. Hanel in the company’s press release. “INSYTE represents a landmark trial that will significantly increase our understanding of brain vessel wall pathologies. Intravascular nOCT imaging will enhance real-time diagnostic insights during these complex procedures.”

Dr. Lopes added, “Initiating enrollment in the INSYTE trial is a significant milestone for Spryte Medical and for the neurointerventional community. This technology has the potential to deliver unprecedented image resolution within the neurovasculature, and this trial will help thoroughly evaluate its safety, performance, and clinical utility.”

Spryte Medical advised that the safety and effectiveness of the nOCT imaging system have not yet been established and that it is an investigational device not approved or cleared by the FDA. The trial is being conducted under an FDA-approved investigational device exemption, noted the company.