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

NCT06516471 | Not Yet Recruiting

• 1 other identifier: B2024-192
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pineal Tumor; Brainstem Tumor; Surgery

Outcome Measures

Primary Outcomes (1)

• Surgical time

  From openning the dura mater to close it

  immedately after surgery

Secondary Outcomes (2)

• Gross total resection rate

  within 72 hours after surgery

• The incidence of complications

  within 1 month after surgery

Study Arms (2)

Mixed Reality Navigation System Group

EXPERIMENTAL

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

Device: Conventinal Navigation System Group

Conventinal Navigation System Group

ACTIVE COMPARATOR

Patients will receive receive surgery guided by traditional navigation system.

Device: Conventinal Navigation System Group

Interventions

Conventinal Navigation System Group DEVICE

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.

Conventinal Navigation System Group; Mixed Reality Navigation System Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recurrent pineal region and brainstem tumors, previously received radiation therapy;
• Combined with serious cardiovascular disease, other systemic malignancies, and other diseases;
• Participants who participate in clinical trials of other drugs or devices but fail to achieve the main research endpoint;
• The subjects are unable or unwilling to participate in this experiment
• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Pinealoma; Brain Stem Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infratentorial Neoplasms

Central Study Contacts

Zeyang Li, M.D.

CONTACT

cqlizeyang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 24, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When final results reported