K44
Conditions
Interventions
Group 1: The aim of the registry-based data collection is to track supplemental 3D visualization using VSI HoloMedicine® to virtually visualize medical DICOM data (CT/MRI) in 3D using augmented realit
Sponsors
apoQlar GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Indication for surgery due to hiatal hernia Preoperative DICOM data already available Consent to study participation in the HerniaMed Registry Consent for additional data collection
Exclusion criteria
Exclusion criteria: Refusal to participate in the HerniaMed Registry Refusal of the additional data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term post-market clinical follow-up (PMCF) (3 months, 1 year, 5 years and 10 years) of performance, clinical benefit and safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection of data from patients undergoing 3D visualization of medical image data (CT thorax/CT upper abdomen) using VSI HoloMedicine®. Comparison of clinical condition, length of stay, operative time, complication rates and recurrence of hiatal hernia in patients with and without patients with and without 3D visualization Evaluation of effectiveness (operative time, length of stay) of patients treated with and without 3D visualization. Long-term follow-up in terms of need for treatment, recurrences, repeat surgeries, pain (with exercise, at rest, longer than 3 months, NAS) and quality of life at the 1 year, 5 year and 10 years Confirmation that no adverse device effects (ADE) occur during use | — |
Countries
Germany
Contacts
Public ContactDirk Weyhe
PIUS-Hospital Oldenburg
Outcome results
None listed