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Recruiting NCT05867927

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

— Observational GYN Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotic-assisted surgery (da Vinci), Non-da Vinci Surgery.
Who it may be relevant to
Registry conditions: GYN Disorders. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study

Overview

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.

Detailed description

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

Interventions

  • Device Robotic-assisted surgery (da Vinci)
    Robotic-assisted surgery (da Vinci)
  • Device Non-da Vinci Surgery
    Non-da Vinci Surgery

Primary outcome measures

  • Number of complications related to the surgery up to 30 days [Time frame: 30 days]
  • Describe the number of patient-reported outcomes up to 12 months [Time frame: 12 months]
  • Characterize the treatment decision as reported by the treating physician [Time frame: 30 days]
Secondary outcome measures (10)
  • Investigate the impact of patient characteristics on surgery [Time frame: 30 days]
  • Investigate the impact of patient characteristics on clinical outcome [Time frame: 30 days]
  • Investigate the impact of patient characteristics on complications [Time frame: 30 days]
  • Describe the impact from surgery to the patient's quality of life and function [Time frame: 12 months]
  • Describe the number of Intuitive instruments used per procedure and patient characteristics [Time frame: 30 days]
  • Describe the number of disease recurrence and re-operation at final patient follow-up [Time frame: 12 months]
  • Describe the number of conversion per procedure and patient characteristics [Time frame: 30 days]
  • Describe the impact of surgeon experience on surgical times (duration of surgery per treating surgeon) [Time frame: 30 days]
  • Describe the impact of surgeon experience on clinical outcome (number of clinical outcomes per treating surgeon) [Time frame: 30 days]
  • Describe the impact of surgeon experience on complications (number of events per surgeon) [Time frame: 30 days]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 15 centers
  • Albertinen Krankenhaus Hamburg — Hamburg
  • St. Josefs-Hospital Wiesbaden — Wiesbaden
  • Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie — Berlin
  • Augusta-Kranken-Anstalt Bochum — Bochum
  • Sana Kliniken Coburg — Coburg
  • St. Elisabeth-Krankenhaus Köln-Hohenlind — Cologne
  • Universitätsklinikum Essen — Essen
  • Agaplesion Markus Krankenhaus Frankfurt am Main — Frankfurt am Main
  • … and 7 more centers

Identifiers

NCT: NCT05867927 · 114363C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗