Robotic-assisted surgery for gynecological conditions
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
Intuitive Surgical · NCT05867927
This study is testing whether robotic-assisted surgery is safer and more effective than traditional surgery for women needing gynecological procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Intuitive Surgical (industry) |
| Locations | 15 sites (Hamburg, Free and Hanseatic City of Hamburg and 14 other locations) |
| Trial ID | NCT05867927 on ClinicalTrials.gov |
What this trial studies
This study aims to generate real-world evidence on the use of da Vinci Surgical Systems for gynecological procedures within the German healthcare system. It is a prospective, non-interventional, multi-center study that evaluates the outcomes of robotic-assisted surgeries compared to traditional surgical methods. Participants will include women aged 18 and older who are candidates for gynecological procedures using the Intuitive Surgical System. The study will collect data on various surgical outcomes to assess the effectiveness and safety of robotic-assisted techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are scheduled for gynecological surgeries that can be performed using robotic assistance.
Not a fit: Patients who are pregnant, have a life expectancy of less than one year, or are currently participating in another clinical study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and patient recovery for women undergoing gynecological procedures.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries in various surgical fields, indicating potential success for this approach in gynecology.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 14 other locations
- Albertinen Krankenhaus Hamburg — Hamburg, Free and Hanseatic City of Hamburg, Germany (RECRUITING)
- St. Josefs-Hospital Wiesbaden — Wiesbaden, Hesse, Germany (RECRUITING)
- Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie — Berlin, Germany (RECRUITING)
- Augusta-Kranken-Anstalt Bochum — Bochum, Germany (RECRUITING)
- Sana Kliniken Coburg — Coburg, Germany (RECRUITING)
- St. Elisabeth-Krankenhaus Köln-Hohenlind — Cologne, Germany (TERMINATED)
- Universitätsklinikum Essen — Essen, Germany (RECRUITING)
- Agaplesion Markus Krankenhaus Frankfurt am Main — Frankfurt am Main, Germany (RECRUITING)
- Universitätsklinikum Freiburg - Klinik für Frauenheilkunde — Freiburg im Breisgau, Germany (RECRUITING)
- Universitätsmedizin Greifswald — Greifswald, Germany (RECRUITING)
- St. Ansgar Krankenhaus Höxter — Höxter, Germany (RECRUITING)
- Universitätsklinikum Kiel — Kiel, Germany (RECRUITING)
- Klinikum Nürnberg Nord / Klinik für Frauenheilkunde — Nuremberg, Germany (RECRUITING)
- Helios Kliniken Schwerin — Schwerin, Germany (RECRUITING)
- Universitätsklinikum Tübingen - Frauenklinik — Tübingen, Germany (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Ingolf Juhasz-Böss, Prof. Dr. — Universitätsklinikum Freiburg
- Study coordinator: Petra Kremer
- Email: petra.kremer@intusurg.com
- Phone: +49 151 62679136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GYN Disorders