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VSI HoloMedicine use in shunt surgeries

VSI HoloMedicine use in shunt surgeries

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029708
Enrollment
10
Registered
2022-07-19
Start date
2022-12-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G91.2

Interventions

Group 1: 10 consecutive shunt surgeries for hydrocephalus
3D visualization of cerebral MRI including color imaging of the ventricular system using VSI Holomedicine, preoperative testing of AI-based segmentation
intraoperative placement of segmented image data over the patient, assessment of endpoints using a review sheet

Sponsors

Neurochirurgie Asklepios Krankenhaus Altona
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with dilated normal pressure hydrocephalus in whom elective hydrocephalus shunt placement is indicated; Ventricular punctures via frontal burr hole trephines only; placement via mixed reality; informed consent; lateral ventricles displayable in VSI

Exclusion criteria

Exclusion criteria: Patients who explicitly refuse intraoperative use of VSI HoloMedicine; patients unable to gave consent

Design outcomes

Primary

MeasureTime frame
To assess whether the use of the VSI HoloMedicine in shunt surgery could facilitate correct surgical insertion of the shunt for neurosurgeons, shorten the duration of surgery, and increase the safety of surgery.

Secondary

MeasureTime frame
Preoperative: Assessment of the accuracy of automatic segmentation of the ventricular system (especially the lateral ventricles) and manual corrections. Intraoperative: Assessment of the accuracy of the placement; Estimation of comfort for the surgeon; Estimated time savings in minutes; Discontinuation of the use of the VSI HoloMedicine application; Estimation of the increase in safety of the surgery due to the use of VSI HoloMedicine on the basis of the above-mentioned points.

Countries

Germany

Contacts

Public ContactPatrick House

Epileptologicum Hamburg

dr.house@epileptologicum.de(040) 480 9693 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026