Status:
RECRUITING
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
Lead Sponsor:
Intuitive Surgical
Conditions:
GYN Disorders
Eligibility:
FEMALE
18+ years
Brief 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 ...
Detailed Description
A prospective, non-interventional, multi-center, post market clinical study.
Eligibility 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT05867927
Start Date
October 25 2023
End Date
March 1 2028
Last Update
March 6 2026
Active Locations (15)
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1
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, Germany, 65189
2
Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
Berlin, Germany, 13353
3
Augusta-Kranken-Anstalt Bochum
Bochum, Germany, 44791
4
Sana Kliniken Coburg
Coburg, Germany, 96450