RecruitingNot Applicable

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

Germany1,250 participantsStarted 2023-10-25

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of complications related to the surgery up to 30 days

Timeframe: 30 days

Describe the number of patient-reported outcomes up to 12 months

Timeframe: 12 months

Characterize the treatment decision as reported by the treating physician

Timeframe: 30 days

Trial details

NCT IDNCT05867927

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Petra Kremer

+49 151 62679136 petra.kremer@intusurg.com

View on ClinicalTrials.gov More GYN Disorders trials