Augmented reality 3D visualization for hiatal hernias
Recruiting
- Conditions
- K44Diaphragmatic hernia
- Registration Number
- DRKS00032266
- Lead Sponsor
- apoQlar GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
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
Refusal to participate in the HerniaMed Registry
Refusal of the additional data collection
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ong-term post-market clinical follow-up (PMCF) (3 months, 1 year, 5 years and 10 years) of performance, clinical benefit and safety
- Secondary Outcome Measures
Name Time Method Collection of data from patients undergoing 3D visualization of medical image data (CT thorax/CT upper abdomen) using VSI HoloMedicine®.<br>Comparison of clinical condition, length of stay, operative time, <br>complication rates and recurrence of hiatal hernia in patients with and without patients with and without 3D visualization <br>Evaluation of effectiveness (operative time, length of stay) of patients treated with and without 3D visualization. <br>Long-term follow-up in terms of need for treatment, recurrences, repeat <br>surgeries, pain (with exercise, at rest, longer than 3 <br>months, NAS) and quality of life at the 1 year, 5 year and 10 years<br>Confirmation that no adverse device effects (ADE) occur during use