Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery

NCT06282224 | Recruiting

• 1 other identifier: XMFHIIT-2023SL066
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

"For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery."

Conditions

Pituitary Neoplasms

Keywords

augmented reality; Transnasal endoscopic surgery; applied research; basicranial tumor

Outcome Measures

Primary Outcomes (2)

• Postoperative Recovery of Transnasal Surgery

  Observe whether the preoperative symptoms (including endocrine abnormalities, impaired visual field, headache, etc.) were alleviated after surgery.

  at the time points of baseline，3 months, 6 months and 1 year after surgery

• Postoperative complication

  Postoperative complication including cerebrospinal fluid leakage, significant neurovascular injury, visual impairment, endocrine disorders, nasal septum perforation and postoperative diabetes insipidus.

  at the time points of baseline，3 months, 6 months and 1 year after surgery

Study Arms (1)

surgery with AR-integrated endoscope

EXPERIMENTAL

Performing endoscopic transnasal skull base surgery with AR-integrated endoscope

Device: Performing endoscopic transnasal skull base surgery with AR-integrated endoscope

Interventions

Performing endoscopic transnasal skull base surgery with AR-integrated endoscope DEVICE

To explore how to use augmented reality technology (AR) to highlight important anatomical structures in the neuroendoscopic field of view, optimize the endoscopic surgical field of view, make up for the shortage of simple endoscopic field of view, make it easier for surgeons to distinguish deep anatomical structures, and reduce the intraoperative and postoperative complications of transnasal endoscopic surgery.

surgery with AR-integrated endoscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are suitable for Transnasal endoscopic surgery 。
• Patients who have performed thin-layer head MRI and CTA scans before surgery.

You may not qualify if:

• Patients without clear preoperative imaging data.
• Patients who do not agree to receive the assistance of AR fusion neuroendoscopy.
• Patients with incomplete medical records.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Hongwei Zhu, doctorate

  The First Affiliated Hospital of Xiamen University

  STUDY DIRECTOR

Central Study Contacts

Hongwei Zhu, doctorate

CONTACT

0086-137 9976 6506; haiwubians@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 28, 2024
• Study Start: January 22, 2024
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Obtain data immediately after publication，indefinite duration
• Access Criteria: anyone

Locations

CN (1)