Investigation of Augmented Reality/Mixed Reality Viewer for Surgical Planning in Cranial Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Brainlab AG
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Quantitative Assessment of Incision Planning Accuracy
研究概览
简要总结
This study is a prospective observational study designed to evaluate the effectiveness of Brainlab's Mixed Reality Viewer in enhancing the accuracy and efficiency of preoperative craniotomy planning. The study will be conducted at a single site with two enrollment groups. Group 1 has a target enrollment of 38 subjects. Group 2 has a target enrollment of 16 subjects. By observing the device's use during standard surgical procedures, we can accurately measure its impact on incision planning accuracy, time efficiency, and overall ease of use compared to traditional neuronavigation systems. This design allows for the collection of both quantitative and qualitative data, providing a robust assessment of the Mixed Reality Viewer's potential to enhance surgical outcome
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brain Tumor Group Inclusion Criteria:
- •Diagnosis: Patients diagnosed with a brain tumor requiring surgical intervention.
- •Age: Adults aged 18 years and older.
- •Consent: Patients who are able to provide written informed consent and are willing to comply with study procedures.
- •Preoperative Imaging: Patients who have undergone standard of care preoperative imaging (e.g., MRI, CT) suitable for use with the Brainlab Mixed Reality Viewer.
- •Surgical Eligibility: Patients deemed eligible for craniotomy based on current clinical standards and the judgment of the attending neurosurgeon.
- •Brain Tumor Group
排除标准
- •Inability to Provide Informed Consent: Subject is unable to provide written informed consent due to cognitive impairment, language barriers, or other reasons that preclude them from understanding the study's requirements.
- •Emergency Surgery: Subject requires emergency craniotomy where there is insufficient time to perform preoperative planning with the Mixed Reality Viewer.
- •Concurrent Participation in Other Clinical Trials: Subject is currently enrolled in another clinical trial that could interfere with the results of this study or place additional burdens on the subject.
- •Unstable Clinical Condition: Subject has a medical condition that is unstable or severe enough to preclude safe participation in the study, as determined by the investigator (e.g., severe cardiac or respiratory conditions).
- •Survey Group Inclusion Criteria:
- •Hospital Personnel: Includes hospital personnel operating or assisting in the brain tumor resection surgeries where the study device is being utilized on an enrolled subject in the study. This includes the Investigators, Clinical Research Coordinator, OR Nurses, and Residents.
- •Age: Adults aged 18 years and older.
- •Consent: Hospital personnel who are able to provide written informed consent and are willing to complete the survey.
- •Survey Group Exclusion Criteria:
- •Inability to Provide Informed Consent: Hospital personnel is unable to provide written informed consent
研究组 & 干预措施
Brain Tumor Group
Subjects with a brain tumor requiring surgical intervention and scheduled to undergo craniotomy where planning of incision and patient positioning is needed
干预措施: Mixed Reality Glasses/Viewer (Device)
Survey Group
Hospital personnel that will be operating or assisting in the craniotomy planning and positioning of subjects enrolled in the Brain Tumor Group and will complete a survey on their experience using the Mixed Reality Viewer
干预措施: Survey using a questionnaire. (Other)
结局指标
主要结局
Quantitative Assessment of Incision Planning Accuracy
时间窗: During the craniotomy incision planning stage that starts when Neurosurgeon begins planning incision on pre-operative cranial planning software (typically the day before surgery) and ends when the incision has been planned in the OR before draping
Determine whether the Mixed Reality Viewer improves the accuracy of incision planning compared to standard neuronavigation. This will be measured by comparing the deviation between the planned and actual incision locations in both methods.
次要结局
- Quantitative Analysis of Incision Time(From when the craniotomy incision planning begins in the OR and ends before draping the subject)
- Quantitative Analysis of Craniotomy Planning Time(From the time craniotomy planning begins in the OR and ends before draping the subject)
- Qualitative Assessment of Planning Ease Using NASA Task Load Index (TLX)(From the start of using the Mixed Reality environment for craniotomy planning in the OR to the final plan before draping the subject)
- Quantitative Analysis of Overall Surgical Time(From the time craniotomy planning begins in the OR and ends before draping the subject)
- Qualitative Assessment of User Satisfaction(through study completion, an average of 1 year)
- Evaluation of Device Safety(through study completion, an average of 1 year)