Robotic-assisted surgery for gynecological conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
  Freiburg im Breisgau, Germany Recruiting
• Universitätsmedizin Greifswald
  Greifswald, Germany Recruiting
• Albertinen Krankenhaus Hamburg
  Hamburg, Free and Hanseatic City of Hamburg, Germany Active not recruiting
• St. Josefs-Hospital Wiesbaden
  Wiesbaden, Hesse, Germany Active not recruiting
• Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
  Berlin, Germany Active not recruiting
• Augusta-Kranken-Anstalt Bochum
  Bochum, Germany Active not recruiting

Study contacts

• Principal investigator: Ingolf Juhasz-Böss, Prof. Dr. — University Hospital Freiburg
• Study coordinator: Petra Kremer
• Email: petra.kremer@intusurg.com
• Phone: +49 151 62679136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.