JURA Study - Observational First-in-human Feasibility Study

Intuitive Surgical

Status: Enrolling

Conditions: Imaging

Treatments: Device: Visualization / Imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT07259759

1145917C

Details and patient eligibility

About

Evaluate the functionality of the JURA System v. 1.0

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

20 participants in 1 patient group

JURA Group

Description:

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.

Treatment:

Device: Visualization / Imaging