NCT07259759

Brief Summary

Evaluate the functionality of the JURA System v. 1.0

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

September 25, 2025

Last Update Submit

April 24, 2026

Conditions

Imaging

Outcome Measures

Primary Outcomes (1)

  • Image quality of the JURA System v. 1.0 in humans

    Image quality of the JURA System v. 1.0 in humans using an image quality assessment score

    Intra-Operative

Study Arms (1)

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

Interventions

Visualization / ImagingDEVICE

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

JURA Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, ZA, 2333, Netherlands

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

December 2, 2025

Study Start

October 31, 2025

Primary Completion

March 27, 2026

Study Completion

March 27, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)