Clinical trial · Interventional
The Evolution of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System in Neurosurgery
The Evolution of Safety and Efficacy of Neuroendoscopy Guided by Head-mounted Mixed Reality Technique Navigation System for Tumor Resection in Pineal Region and Brainstem: A Prospective, Randomized, Parallel-controlled Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brainstem Tumor | Brain Stem Neoplasm | ALIAS | 0.90 |
| Pineal Tumor | Pineal Region Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventinal Navigation System Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mixed Reality Navigation System Group
- description
- Patients will receive receive surgery guided by mixed reality technique navigation system.
- interventionNames
- Device: Conventinal Navigation System Group
- type
- ACTIVE_COMPARATOR
- label
- Conventinal Navigation System Group
- description
- Patients will receive receive surgery guided by traditional navigation system.
- interventionNames
- Device: Conventinal Navigation System Group
Primary outcomes (1)
- measure
- Surgical time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available