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Real-time Craniotomie Planning met Mixed Reality

30 september 2026 bijgewerkt door: Brainlab AG

Onderzoek naar Augmented Reality/Mixed Reality Viewer voor chirurgische planning bij schedelchirurgie

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

54

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham and Women's Hospital, Inc.
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult patients diagnosed with a brain tumor scheduled to undergo surgical intervention where craniotomy planning is needed to plan incision and patient positioning.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Apparaat: Mixed Reality Glasses/Viewer

Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning
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
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quantitative Assessment of Incision Planning Accuracy
Tijdsspanne: 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.
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quantitative Analysis of Incision Time
Tijdsspanne: From when the craniotomy incision planning begins in the OR and ends before draping the subject

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
Quantitative Analysis of Craniotomy Planning Time
Tijdsspanne: From the time craniotomy planning begins in the OR and ends before draping the subject

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
Qualitative Assessment of Planning Ease Using NASA Task Load Index (TLX)
Tijdsspanne: From the start of using the Mixed Reality environment for craniotomy planning in the OR to the final plan before draping the subject

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
Quantitative Analysis of Overall Surgical Time
Tijdsspanne: From the time craniotomy planning begins in the OR and ends before draping the subject

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
Qualitative Assessment of User Satisfaction
Tijdsspanne: through study completion, an average of 1 year

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
Evaluation of Device Safety
Tijdsspanne: through study completion, an average of 1 year

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Brainlab AG

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

3 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 maart 2026

Eerst geplaatst (Werkelijk)

12 maart 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 24-653

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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