JURA Study - Observational First-in-human Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-05-31

Brief Summary

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Evaluate the functionality of the JURA System v. 1.0

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Detailed Description

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Evaluate the functionality of the JURA System v. 1.0 in humans under real clinical conditions in the operating room

Conditions

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Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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JURA Group

Visualization of organs, structures and tissue of interest using the JURA System during a surgical procedure. The surgical procedure itself will be conducted exclusively following the site standard of care.

Visualization / Imaging

Intervention Type DEVICE

Visualization / Imaging of organs, structures and tissue of interest using the JURA system such as for example spleen, anastomosis of colon, omental fat, pancreas

Interventions

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Visualization / 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Men and women ≥ 18 years of age
2. Patient scheduled for an elective abdominal minimal invasive surgery

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No