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JURA - Observational first-in-human feasibility study

JURA - Observational first-in-human feasibility study - JURA - Observational first-in-human feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57999
Enrollment
24
Registered
2025-02-19
Start date
2025-10-30
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Colon resection

Interventions

The JURA System v. 1.0 is an investigational device intended to visualize tissue oxygenation (StO2) in real-time.&nbsp
It is composed of a JURA endoscope system controller which houses a laser capable of differentiating oxygenated and deoxygenated blood. A JURA endoscope connects to the endoscope system controller and
The JURA system v 1.0 will be used at certain timepoints of the standard robotic procedure to image target organs. For the purpose of the study, the oxygenation image will not be displayed to the surg

Sponsors

Intuitive Surgical Sàrl
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men and women = 18 years of agePatient scheduled for an elective abdominal minimal invasive surgery conducted with a da Vinci Surgical System (X or Xi)Patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent

Exclusion criteria

Exclusion criteria: Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding womenIndividuals 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 Procedures where a colostomy bag is pre-operatively planned

Design outcomes

Primary

MeasureTime frame
Evaluation of the image quality of the JURA System v. 1.0 in humans

Secondary

MeasureTime frame
Evaluation of the level of oxygenation (StO2) of multiple abdominal organ and tissue types

Countries

Netherlands

Contacts

Public ContactSG Gioux

Intuitive Surgical Sàrl

Sylvain.Gioux@intusurg.com0041799246664

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026