GYN DisordersGENERATENCT05867927
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
An observational study of GYN Disorders, run by Intuitive Surgical at 15 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- GYN Disorders
- What is being tested?
- Robotic-assisted surgery (da Vinci) and Non-da Vinci Surgery
- Type of treatment
- Medical device
- How many people
- 1,250 participants
- Where
- 15 sitesGermany
- Study dates
- 25 Oct 2023to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gynecological disease that may be treated by surgical intervention.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Germany15 sites, 2 recruiting
- Active, not recruiting
Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
Berlin, 13353
- Active, not recruiting
Augusta-Kranken-Anstalt Bochum
Bochum, 44791
- Active, not recruiting
Sana Kliniken Coburg
Coburg, 96450
- Terminated
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, 50935
- Active, not recruiting
Universitätsklinikum Essen
Essen, 45147
- Active, not recruiting
Agaplesion Markus Krankenhaus Frankfurt am Main
Frankfurt am Main, 60431
- Recruiting
Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
Freiburg im Breisgau, 79106
Markus Hübner, Prof. Dr.
- Recruiting
Universitätsmedizin Greifswald
Greifswald, 17475
Zaher Alwafai, Dr., +49 3834 86 6500, zaher.alwafai@med.uni-greifswald.de
- Active, not recruiting
Albertinen Krankenhaus Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 22457
- Active, not recruiting
St. Ansgar Krankenhaus Höxter
Höxter, 37671
- Active, not recruiting
Universitätsklinikum Kiel
Kiel, 24105
- Active, not recruiting
Klinikum Nürnberg Nord / Klinik für Frauenheilkunde
Nuremberg, 90419
- Active, not recruiting
Helios Kliniken Schwerin
Schwerin, 19055
- Active, not recruiting
Universitätsklinikum Tübingen - Frauenklinik
Tübingen, 72076
- Active, not recruiting
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, 65189
About this study
Official title: GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
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.
Read the detailed description
A prospective, non-interventional, multi-center, post market clinical study.
- Conditions
- GYN Disorders
- Being tested
- Robotic-assisted surgery (da Vinci), Non-da Vinci Surgery
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted surgery (da Vinci)Device
Robotic-assisted surgery (da Vinci)
Non-da Vinci SurgeryDevice
Non-da Vinci Surgery
| Study group | Role | What they receive |
|---|---|---|
| da Vinci Patients | Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery Receives: Device: Robotic-assisted surgery (da Vinci) | |
| 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 Receives: Device: Non-da Vinci Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 30 days
Secondary outcomes (10)
Investigate the impact of patient characteristics on surgery
Descriptive analysis of patient characteristics such as age on surgery (e.g., duration of surgery, instrument usage)
Measured: 30 days
Investigate the impact of patient characteristics on clinical outcome
Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation)
Measured: 30 days
Investigate the impact of patient characteristics on complications
Descriptive analysis of patient characteristics such as age on complication (number of complications reported during and after the surgery)
Measured: 30 days
Describe the impact from surgery to the patient's quality of life and function
Describe the impact from surgery to the patient's quality of life and function by comparing the baseline quality of life and functional status with the post-operative status (post-operative day 1-3, 30 days, 90 days, 6 months and 12 months)
Measured: 12 months
Describe the number of Intuitive instruments used per procedure and patient characteristics
Describe the number of Intuitive instruments used per procedure and patient characteristics; descriptive analysis will be performed on the number of instruments used per specific procedure and patient
Measured: 30 days
Describe the number of disease recurrence and re-operation at final patient follow-up
Describe the number disease recurrence and re-operation at final patient follow-up; descriptive analysis will be performed
Measured: 12 months
Describe the number of conversion per procedure and patient characteristics
Describe the number conversion per procedure and patient characteristics; descriptive analysis will be performed
Measured: 30 days
Describe the impact of surgeon experience on surgical times (duration of surgery per treating surgeon)
Describe the impact of surgeon experience on surgical times, descriptive analysis will be performed on the surgical times (duration of surgery) per treating surgeon
Measured: 30 days
Describe the impact of surgeon experience on clinical outcome (number of clinical outcomes per treating surgeon)
Describe the impact of surgeon experience on clinical outcome; descriptive analysis will be performed, e.g., on number of re-operation or re-hospitalization per treating surgeon
Measured: 30 days
Describe the impact of surgeon experience on complications (number of events per surgeon)
Describe the impact of surgeon experience on complications; descriptive analysis will be performed on number of adverse events per treating surgeon
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start25 Oct 2023
- Primary completionFeb 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GYN DisordersStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingolf Juhasz-Böss, Prof. Dr., Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867927
- Sponsor's protocol ID
- 114363C
- Acronym
- GENERATE
- Status last verified
- Nov 2026
- First submitted
- 2 May 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
- ClinicalTrials.gov ID
- NCT05867927
- Acronym / sponsor ID
- GENERATE / 114363C
- Conditions
- GYN Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| da Vinci Patients | – | Device: Robotic-assisted surgery (da Vinci)Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery |
| Epidemiological Data Audit | – | Device: Non-da Vinci SurgeryExtended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gynecological disease that may be treated by surgical intervention.
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted surgery (da Vinci)Robotic-assisted surgery (da Vinci) | Device | da Vinci Patients |
| Non-da Vinci SurgeryNon-da Vinci Surgery | Device | Epidemiological Data Audit |
Primary outcome
Number of complications related to the surgery up to 30 days
Time frame: 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.
Describe the number of patient-reported outcomes up to 12 months
Time frame: 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
Characterize the treatment decision as reported by the treating physician
Time frame: 30 days
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingolf Juhasz-Böss, Prof. Dr. principal investigator
University Hospital Freiburg
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GYN Disorders, run by Intuitive Surgical at 15 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Kremer (+49 151 62679136, petra.kremer@intusurg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications related to the surgery up to 30 days (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.