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NCT05867927 | Recruiting | GYN Disorders


GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
Sponsor:

Intuitive Surgical

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 Xi/X Surgical Systems for gynecological indications within the German health care system.

Condition or disease

GYN Disorders

Intervention/treatment

Robotic-assisted surgery (da Vinci)

Non-da Vinci Surgery

Detailed Description:

A prospective, non-interventional, multi-center, post market clinical study.

Study Type : Observational
Estimated Enrollment : 1125 participants
Official Title: GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
Actual Study Start Date : October 25, 2023
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : June 2027

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Location Details


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GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Germany,

Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie

Berlin, Germany, 13353

Recruiting

Germany,

Universitätsklinikum Freiburg - Klinik für Frauenheilkunde

Freiburg, Germany, 79106

Recruiting

Germany,

Albertinen Krankenhaus Hamburg

Hamburg, Germany, 22457

Recruiting

Germany,

St. Elisabeth-Krankenhaus Köln-Hohenlind

Köln, Germany, 50935

Recruiting

Germany,

Klinikum Nürnberg Nord / Klinik für Frauenheilkunde

Nürnberg, Germany, 90419

Recruiting

Germany,

Universitätsklinikum Tübingen - Frauenklinik

Tübingen, Germany, 72076

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