NCT05867927 GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
| NCT ID | NCT05867927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Intuitive Surgical |
| Condition | GYN Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,250 participants in total. It began in 2023-10-25 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 indications within the German health care system.
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
Contact & Investigator
Ingolf Juhasz-Böss, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital Freiburg
Frequently Asked Questions
Who can join the NCT05867927 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying GYN Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05867927 currently recruiting?
Yes, NCT05867927 is actively recruiting participants. Contact the research team at petra.kremer@intusurg.com for enrollment information.
Where is the NCT05867927 trial being conducted?
This trial is being conducted at Hamburg, Germany, Wiesbaden, Germany, Berlin, Germany, Bochum, Germany and 11 additional locations.
Who is sponsoring the NCT05867927 clinical trial?
NCT05867927 is sponsored by Intuitive Surgical. The principal investigator is Ingolf Juhasz-Böss, Prof. Dr. at University Hospital Freiburg. The trial plans to enroll 1,250 participants.