Echtzeit-Kraniotomieplanung mit Mixed Reality
Untersuchung eines Augmented-Reality-/Mixed-Reality-Betrachters für die chirurgische Planung in der Schädelchirurgie
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham and Women's Hospital, Inc.
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Kontakt:
- Paramjai Sandhu
- Telefonnummer: 617-632-3029
- E-Mail: psandhu2@bwh.harvard.edu
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adult patients diagnosed with a brain tumor scheduled to undergo surgical intervention where craniotomy planning is needed to plan incision and patient positioning.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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 |
Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning |
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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 |
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quantitative Assessment of Incision Planning Accuracy
Zeitfenster: 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
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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. |
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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quantitative Analysis of Incision Time
Zeitfenster: From when the craniotomy incision planning begins in the OR and ends before draping the subject
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Assess whether the use of the Mixed Reality Viewer leads to a reduction in the time taken to perform the incision, compared to the standard neuronavigation incision planning. |
From when the craniotomy incision planning begins in the OR and ends before draping the subject
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Quantitative Analysis of Craniotomy Planning Time
Zeitfenster: From the time craniotomy planning begins in the OR and ends before draping the subject
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Evaluate if the Mixed Reality Viewer decreases the time required to plan the craniotomy compared to standard neuronavigation planning methods. |
From the time craniotomy planning begins in the OR and ends before draping the subject
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Qualitative Assessment of Planning Ease Using NASA Task Load Index (TLX)
Zeitfenster: From the start of using the Mixed Reality environment for craniotomy planning in the OR to the final plan before draping the subject
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Assess whether the Mixed Reality Viewer improves the ease and overall user experience of operative planning as compared to standard methods, using the NASA TLX survey tool for subjective workload assessment. |
From the start of using the Mixed Reality environment for craniotomy planning in the OR to the final plan before draping the subject
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Quantitative Analysis of Overall Surgical Time
Zeitfenster: From the time craniotomy planning begins in the OR and ends before draping the subject
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Measure the overall time from the beginning of the surgical planning to the completion of the incision to determine if the Mixed Reality Viewer contributes to a more efficient surgical workflow. |
From the time craniotomy planning begins in the OR and ends before draping the subject
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Qualitative Assessment of User Satisfaction
Zeitfenster: through study completion, an average of 1 year
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Collect feedback from surgeons and surgical staff regarding their satisfaction with the Mixed Reality Viewer compared to standard methods, using structured interviews or surveys. |
through study completion, an average of 1 year
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Evaluation of Device Safety
Zeitfenster: through study completion, an average of 1 year
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Monitor and record any adverse events or complications associated with the use of the Mixed Reality Viewer during the surgical planning and execution phases. |
through study completion, an average of 1 year
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 24-653
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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