GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Intuitive Surgical

Status: Enrolling

Conditions: GYN Disorders

Treatments: Device: Robotic-assisted surgery (da Vinci); Device: Non-da Vinci Surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05867927

114363C

Details and patient eligibility

About

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Generate real-world evidence in the use of the da Vinci Surgical Systems for gynecological indications within the German health care system.

Full description

A prospective, non-interventional, multi-center, post market clinical study.

Enrollment: 1,250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Woman with 18 years of age or older
• Patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent
• Patient is a candidate for a gynecological procedure to be performed with the Intuitive Surgical System

Key Exclusion Criteria:

• Life expectancy of less than 1 year
• Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women
• Current participation in a clinical study, if not pre-approved by Intuitive
• Individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliation

Trial design

1,250 participants in 2 patient groups

da Vinci Patients

Description:

Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery

Treatment:

Device: Robotic-assisted surgery (da Vinci)

Epidemiological Data Audit

Description:

Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery

Treatment:

Device: Non-da Vinci Surgery