Imaging
Conditions
Brief summary
Evaluate the functionality of the JURA System v. 1.0
Detailed description
Evaluate the functionality of the JURA System v. 1.0 in humans under real clinical conditions in the operating room
Interventions
DEVICEVisualization / Imaging
Visualization / Imaging of organs, structures and tissue of interest using the JURA system such as for example spleen, anastomosis of colon, omental fat, pancreas
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Men and women ≥ 18 years of age 2. Patient scheduled for an elective abdominal minimal invasive surgery Key
Exclusion criteria
1. Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women 2. Individuals who are unable to fully understand all aspects of the study as relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced due to of a compromised position, expectation or benefits or fear or retaliation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image quality of the JURA System v. 1.0 in humans | Intra-Operative | Image quality of the JURA System v. 1.0 in humans using an image quality assessment score |
Countries
Netherlands
Outcome results
None listed