GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
Intuitive Surgical
1,250 participants
Oct 25, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria4
- 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
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Interventions
Robotic-assisted surgery (da Vinci)
Non-da Vinci Surgery
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05867927