RecruitingNCT05867927

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


Sponsor

Intuitive Surgical

Enrollment

1,250 participants

Start Date

Oct 25, 2023

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

DEVICERobotic-assisted surgery (da Vinci)

Robotic-assisted surgery (da Vinci)

DEVICENon-da Vinci Surgery

Non-da Vinci Surgery


Locations(15)

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

Albertinen Krankenhaus Hamburg

Hamburg, 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

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NCT05867927


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