GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GENERATE
1 other identifier
observational
1,250
1 country
15
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 Surgical Systems for gynecological indications within the German health care system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 5, 2026
May 1, 2026
4.1 years
May 2, 2023
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of complications related to the surgery up to 30 days
Describe the number of complications related to the surgery up to 30 days; adverse events as documented during the first 30 days will be classified as four different levels of causality to the surgery (not related, possible, probable and causal relationship). Descriptive analysis will be performed.
30 days
Describe the number of patient-reported outcomes up to 12 months
Describe the patient-reported outcomes up to 12 months; descriptive analysis will be performed on the data directly reported via the patients (patient questionnaires); information included are number of complications, re-hospitalizations, re-operations, disease recurrence, disease remission, new disease diagnosis and pain status including pain medication
12 months
Characterize the treatment decision as reported by the treating physician
Characterize the treatment decision per data provided by the treating physician (within the study database) including the rationale given for the treatment decision (e.g., age of the patient or co-morbidity); number of treatment decisions, e.g., for surgical therapy (open surgery or minimal-invasive therapy), watchful waiting, or treatment with medication will be described; descriptive analysis will be performed
30 days
Secondary Outcomes (10)
Investigate the impact of patient characteristics on surgery
30 days
Investigate the impact of patient characteristics on clinical outcome
30 days
Investigate the impact of patient characteristics on complications
30 days
Describe the impact from surgery to the patient's quality of life and function
12 months
Describe the number of Intuitive instruments used per procedure and patient characteristics
30 days
- +5 more secondary outcomes
Study Arms (2)
da Vinci Patients
Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery
Epidemiological Data Audit
Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery
Interventions
Eligibility Criteria
Patients with gynecological disease that may be treated by surgical intervention.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Albertinen Krankenhaus Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 22457, Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, 65189, Germany
Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
Berlin, 13353, Germany
Augusta-Kranken-Anstalt Bochum
Bochum, 44791, Germany
Sana Kliniken Coburg
Coburg, 96450, Germany
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, 50935, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Agaplesion Markus Krankenhaus Frankfurt am Main
Frankfurt am Main, 60431, Germany
Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
Freiburg im Breisgau, 79106, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
St. Ansgar Krankenhaus Höxter
Höxter, 37671, Germany
Universitätsklinikum Kiel
Kiel, 24105, Germany
Klinikum Nürnberg Nord / Klinik für Frauenheilkunde
Nuremberg, 90419, Germany
Helios Kliniken Schwerin
Schwerin, 19055, Germany
Universitätsklinikum Tübingen - Frauenklinik
Tübingen, 72076, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingolf Juhasz-Böss, Prof. Dr.
Universitätsklinikum Freiburg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2023
First Posted
May 22, 2023
Study Start
October 25, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share