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„KARVIMIO“ – „KI-basierte Augmented Reality Visualisierung von Bedienungsanleitungen medizinischer Instrumente im Operationssaal“ – Augmented reality in surgical preparation

„KARVIMIO“ – „KI-basierte Augmented Reality Visualisierung von Bedienungsanleitungen medizinischer Instrumente im Operationssaal“ – Augmented reality in surgical preparation - KARVIMIO Surgical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038271
Enrollment
5
Registered
2025-10-28
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Augmented reality in the operating room

Interventions

Group 1: In an operating environment, orthopedic instrument sets are prepared for surgery by being recognized using AI and displaying the operating instructions to the subjects using augmented reality

Sponsors

Medability GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? All participants must be capable of giving consent. ? Sufficient knowledge of English or German. ? Basic knowledge of surgical techniques: Participants should have basic knowledge and experience in the operating room in order to be able to adequately assess the performance of surgical tasks (assembly of medical instruments). ? Voluntary participation: Participation in the study is voluntary. It is possible to withdraw from the study at any time without negative consequences.

Exclusion criteria

Exclusion criteria: ? Participants with known medical conditions or limitations that could prevent them from safely performing the simulation or using the AR glasses should be excluded (e.g., known epilepsy). ? Participants with known allergies or intolerances to the materials used in the AR glasses should be excluded to avoid possible allergic reactions. ? Participants who are unable to understand the instructions or perform the study tasks adequately due to language barriers or cognitive limitations should be excluded.

Design outcomes

Primary

MeasureTime frame
Error reduction through the use of AI and AR-based technology.

Secondary

MeasureTime frame
Improved subjective user safety of test subjects using questionnaires to assess cognitive load using the surgery task load index (SURG-TLX), the “User Experience Questionnaire,” and the adapted “UTAUT” questionnaire to assess cognitive load, usability, user experience, and technology acceptance for AR, as well as qualitative feedback from test subjects.

Countries

Germany

Contacts

Public ContactSebastian Andreß

LMU Klinikum

sebastian.andress@med.uni-muenchen.de+49 89 4400 712245

Outcome results

None listed

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