The Evolution of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System in Neurosurgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Preoperative suspicion of pineal region and brainstem tumors; 2. Age range from 18 to 70 years old; 3. Preoperative neurological function was good, with KPS>70 points; 4. Informed consent of patients and their families;

Exclusion Criteria:

1. Recurrent pineal region and brainstem tumors, previously received radiation therapy; 2. Combined with serious cardiovascular disease, other systemic malignancies, and other diseases; 3. Participants who participate in clinical trials of other drugs or devices but fail to achieve the main research endpoint; 4. The subjects are unable or unwilling to participate in this experiment. 5. Preoperative discussion considers that patients are unable to undergo neurosurgical endoscopic surgery and require the use of microscopy or other techniques to assist in tumor resection;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06516471
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Zhongshan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pineal Tumor, Brainstem Tumor, Surgery

Additional Details

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 patient's 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.

Arms & Interventions

Arms

Experimental: Mixed Reality Navigation System Group

Patients will receive receive surgery guided by mixed reality technique navigation system.

Active Comparator: Conventinal Navigation System Group

Patients will receive receive surgery guided by traditional navigation system.

Interventions

Device: - Conventinal Navigation System Group

The preoperative planned model is projected onto the endoscopic display area in 3D using a mixed reality headset, accurately matching the actual anatomical structure and tissue displayed under the patient's endoscope to guide surgical resection of tumors.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Zeyang Li, M.D.

[email protected]

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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