JURA Study - Observational First-in-human Feasibility Study (JURA)

April 24, 2026 updated by: Intuitive Surgical
Evaluate the functionality of the JURA System v. 1.0

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • ZA
      • Leiden, ZA, Netherlands, 2333
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men and women above the age of 18 year, scheduled for an elective abdominal minimal invasive surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality of the JURA System v. 1.0 in humans
Time Frame: Intra-Operative
Image quality of the JURA System v. 1.0 in humans using an image quality assessment score
Intra-Operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Actual)

March 27, 2026

Study Completion (Actual)

March 27, 2026

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1145917C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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