Actively Recruiting
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
Led by Intuitive Surgical · Updated on 2026-06-03
1250
Participants Needed
15
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to generate real-world evidence on the use of the da Vinci Surgical Systems for gynecological conditions within the German health care system. It is a prospective, non-interventional, multi-center, post-market clinical study sponsored by Intuitive Surgical. The study includes women aged 18 and older who are candidates for gynecological procedures and evaluates robotic-assisted surgery compared to other surgical methods. Participants are enrolled consecutively into two groups: those undergoing robotic-assisted surgery using the da Vinci system and those eligible for robotic surgery but receiving non-da Vinci surgical treatments. The study collects extended data on patient and surgical characteristics, treatment decisions, and outcomes. Follow-up includes assessments up to 12 months after surgery. During the study, researchers will monitor surgical complications within 30 days, patient-reported outcomes up to 12 months, and treatment decisions reported by physicians. They will also evaluate the impact of patient characteristics and surgeon experience on surgical times, clinical outcomes, and complications. Quality of life, disease recurrence, re-operation rates, and use of surgical instruments will be documented to understand the overall effects of the procedures.
CONDITIONS
Brief Title
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman with 18 years of age or older
- Willing to participate and comply with study procedures by signing informed consent
- Candidate for a gynecological procedure to be performed with the Intuitive Surgical System
You will not qualify if you...
- Life expectancy less than 1 year
- Pregnancy, positive pregnancy test prior to menopause, or breastfeeding
- Current participation in a clinical study without pre-approval by Intuitive Surgical
- Unable to understand study aspects relevant to participation or subject to undue influence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo either robotic-assisted surgery or non-robotic surgery as part of their gynecological procedure.
Approximately 1 to 2 visits depending on the surgery and follow-up
Duration - Up to 12 months
Participants are followed for up to 12 months to assess patient-reported outcomes, quality of life, function, disease recurrence, and re-operation.
Periodic visits up to 12 months
Trial Site Locations
Total: 15 locations
1
Albertinen Krankenhaus Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany, 22457
Actively Recruiting
2
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, Germany, 65189
Actively Recruiting
3
Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
Berlin, Germany, 13353
Actively Recruiting
4
Augusta-Kranken-Anstalt Bochum
Bochum, Germany, 44791
Actively Recruiting
5
Sana Kliniken Coburg
Coburg, Germany, 96450
Actively Recruiting
6
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, Germany, 50935
Terminated
7
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
8
Agaplesion Markus Krankenhaus Frankfurt am Main
Frankfurt am Main, Germany, 60431
Actively Recruiting
9
Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
10
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
Actively Recruiting
11
St. Ansgar Krankenhaus Höxter
Höxter, Germany, 37671
Actively Recruiting
12
Universitätsklinikum Kiel
Kiel, Germany, 24105
Actively Recruiting
13
Klinikum Nürnberg Nord / Klinik für Frauenheilkunde
Nuremberg, Germany, 90419
Actively Recruiting
14
Helios Kliniken Schwerin
Schwerin, Germany, 19055
Actively Recruiting
15
Universitätsklinikum Tübingen - Frauenklinik
Tübingen, Germany, 72076
Active, Not Recruiting
Research Team
P
Petra Kremer
P
Peter Appenrodt
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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