C25 K35 K56 K80
Conditions
Interventions
Group 1: The Remote Assist application allows discussion or collaboration in teams with a shared view of a patient-specific case. A post-market follow-up (PMCF) observation will confirm the safety as
Sponsors
apoQlar GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients in the Department of General and Visceral Surgery with treatment under one of the three observation scenarios Consent to participate in the study Capacity to consent
Exclusion criteria
Exclusion criteria: Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Remote Assist application enables discussion or collaboration in teams with a shared view of a patient-specific case. A post-market follow-up (PMCF) observation will confirm the safety as well as an acceptable benefit/risk ratio of the tool in different scenarios. Instead of the telephone or other means of communication, remote assist via VSI HoloMedicine® of the MS Team tool will be used in three different scenarios. The following scenarios are evaluated: Adding to the operating room (Whipple) (n=3), indication discussion with colleagues (n=3), and emergency support (ileus, cholelithiasis, appendicitis). The aim is long-term post-marketing clinical follow-up (PMCF) of the performance, clinical utility, and safety of the product with respect to MS Teams use of VSI HoloMedicine®. | — |
Secondary
| Measure | Time frame |
|---|---|
| The purpose of this qualitative study is to evaluate the teams use of VSI HoloMedicine®, in the context of surgery, physician on-call, and the emergency department for the following purposes. Evaluate: Confirm the performance of the teams integration of VSI HoloMedicine® (remote assist / 3D hologram / streaming / voice quality). Deployment in different scenarios (OR / emergency / on-call) in terms of remote collaboration. Evaluation of usability, advantages and disadvantages Confirmation of the safety of the medical device Satisfaction of the users Observation of any unforeseen risks related to the function, Ensuring continued acceptance of the risk-benefit ratio. Measurement of mental workload (NASA-TLX). | — |
Countries
Germany
Contacts
Public ContactDirk Weyhe
PIUS-Hospital Oldenburg
Outcome results
None listed