Viewing Study NCT06516471



Ignite Creation Date: 2024-10-26 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06516471
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-06-21

Brief Title: The Evolution of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System in Neurosurgery
Sponsor: None
Organization: None

Study Overview

Official Title: The Evolution of Safety and Efficacy of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System for Tumor Resection in Pineal Region and Brainstem A Prospective Randomized Parallel-controlled Clinical Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The pineal region and brainstem tumors are located at the central position of the cranial cavity surrounded by important neural structures and venous systems leading to challenges in preoperative diagnosis adding uncertainty and complexity to treatment For a long time surgical treatment of pineal region and brainstem tumors has been one of the most challenging areas in neurosurgery

With the development of neuroendoscopy and virtual endoscopy technologies how to convert complex three-dimensional bone vascular and neural images into virtual endoscopic images and how to combine virtual endoscopy with neuro-navigation for endoscopic skull base surgery to provide high-quality guidance images for surgery has become an urgent new research issue

The project team plans to develop a neuroendoscopy combined with a wearable mixed reality glasses navigation system integrating the advantages of wearable glasses and existing surgical navigation systems

This study aims to evaluate the role of mixed reality navigation systems in improving total resection and reducing major complications in patients with pineal region and brainstem tumors as well as shortening surgical times
Detailed Description: The pineal region and brainstem tumors are located at the central position of the cranial cavity surrounded by important neural structures and venous systems They contain many crucial neural functional nuclei making surgical exposure and resection difficult Furthermore the tumors in this region exhibit complex and diverse pathological types including mixed tumors leading to challenges in preoperative diagnosis adding uncertainty and complexity to treatment Pineal region tumors commonly cause obstructive hydrocephalus resulting in severe preoperative intracranial hypertension symptoms further complicating surgical management For a long time surgical treatment of pineal region and brainstem tumors has been one of the most challenging areas in neurosurgery

With the development of neuroendoscopy and virtual endoscopy technologies how to convert complex three-dimensional bone vascular and neural images into virtual endoscopic images and how to combine virtual endoscopy with neuro-navigation for endoscopic skull base surgery to provide high-quality guidance images for surgery has become an urgent new research issue

The project team plans to develop a neuroendoscopy combined with a wearable mixed reality glasses navigation system integrating the advantages of wearable glasses and existing surgical navigation systems While ensuring the accuracy of the navigation system the team aims to fundamentally change the output method of the system enabling the surgical navigation system to go beyond mere validation of effects and truly play a role of intuitive visual navigation By holographically observing and tracking the relevant blood vessels and nerves in the patients area the team has achieved high-precision integration of virtual and real microanatomy structures allowing for better and safer handling of deep-seated tumors under the endoscope This study aims to evaluate the role of mixed reality navigation systems in improving total resection and reducing major complications in patients with pineal region and brainstem tumors as well as shortening surgical times

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None