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Набор скоро начнётся NCT07468370

Real Time Craniotomy Planning Using Mixed Reality

— Наблюдательное Neurosurgery Surgical Planning Brain Tumor Adult Craniotomy Tumor Removal Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mixed Reality Glasses/Viewer, Survey using a questionnaire..
Кому может быть актуально
Состояния в реестре: Neurosurgery, Surgical Planning, Brain Tumor Adult, Craniotomy Tumor Removal Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Investigation of Augmented Reality/Mixed Reality Viewer for Surgical Planning in Cranial Surgery

Обзор

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

Вмешательства

  • Устройство Mixed Reality Glasses/Viewer
    Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning
  • Другое Survey using a questionnaire.
    A survey will be completed by hospital personnel that use the mixed reality environment (glasse and viewer) to evaluate craniotomy planning for participants in the Brain Tumor Group

Первичные конечные точки

  • Quantitative Assessment of Incision Planning Accuracy [Срок оценки: 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]
Вторичные конечные точки (6)
  • Quantitative Analysis of Incision Time [Срок оценки: From when the craniotomy incision planning begins in the OR and ends before draping the subject]
  • Quantitative Analysis of Craniotomy Planning Time [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From the time craniotomy planning begins in the OR and ends before draping the subject]
  • Qualitative Assessment of User Satisfaction [Срок оценки: through study completion, an average of 1 year]
  • Evaluation of Device Safety [Срок оценки: through study completion, an average of 1 year]

Критерии участия

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 Exclusion Criteria:

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Brigham and Women's Hospital, Inc. — Boston

Идентификаторы

NCT: NCT07468370 · 24-653

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗