Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

"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."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are suitable for Transnasal endoscopic surgery 。

Patients who have performed thin-layer head MRI and CTA scans before surgery.

Disqualifiers

Patients without clear preoperative imaging data.

Patients who do not agree to receive the assistance of AR fusion neuroendoscopy.

Patients with incomplete medical records.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: surgery with AR-integrated endoscopeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Recovery of Transnasal Surgery

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

Time frame
at the time points of baseline,3 months, 6 months and 1 year after surgery
2

Postoperative complication

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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