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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Mixed Reality Navigation System GroupExperimental treatment 1 intervention
Group B: Conventinal Navigation System GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical time

From openning the dura mater to close it

Time frame
immedately after surgery

Secondary outcomes

1

Gross total resection rate

Gross total was defined as 100% of tumor resection

Time frame
within 72 hours after surgery
2

The incidence of complications

new cranial nerve dysfunction, secondary surgery

Time frame
within 1 month after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: