GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
NCT ID: NCT05867927
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1250 participants
OBSERVATIONAL
2023-10-25
2028-03-31
Brief Summary
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Generate real-world evidence in the use of the da Vinci Surgical Systems for gynecological indications within the German health care system.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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da Vinci Patients
Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery
Robotic-assisted surgery (da Vinci)
Robotic-assisted surgery (da Vinci)
Epidemiological Data Audit
Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery
Non-da Vinci Surgery
Non-da Vinci Surgery
Interventions
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Robotic-assisted surgery (da Vinci)
Robotic-assisted surgery (da Vinci)
Non-da Vinci Surgery
Non-da Vinci Surgery
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Principal Investigators
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Ingolf Juhasz-Böss, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Freiburg
Locations
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Albertinen Krankenhaus Hamburg
Hamburg, Hamburg, Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, Germany
Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
Berlin, , Germany
Augusta-Kranken-Anstalt Bochum
Bochum, , Germany
Sana Kliniken Coburg
Coburg, , Germany
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, , Germany
Universitätsklinikum Essen
Essen, , Germany
Agaplesion Markus Krankenhaus Frankfurt am Main
Frankfurt am Main, , Germany
Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
Freiburg im Breisgau, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
St. Ansgar Krankenhaus Höxter
Höxter, , Germany
Universitätsklinikum Kiel
Kiel, , Germany
Klinikum Nürnberg Nord / Klinik für Frauenheilkunde
Nuremberg, , Germany
Helios Kliniken Schwerin
Schwerin, , Germany
Universitätsklinikum Tübingen - Frauenklinik
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Rüdiger Klapdor, Prof. Dr.
Role: primary
Mustafa Zefal Muallem, Prof. Dr.
Role: primary
Matthias Losch, Dr.
Role: primary
Marc Thill, Prof. Dr.
Role: primary
Markus Hübner, Prof. Dr.
Role: primary
Ibrahim Alkatout, Prof. Dr.
Role: primary
Dimitrios Bolovis, Prof. Dr.
Role: primary
Nicole Stahl
Role: primary
Other Identifiers
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114363C
Identifier Type: -
Identifier Source: org_study_id
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