An observational study in GYN Disorders, sponsored by Intuitive Surgical. Recruiting at 15 sites in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Intuitive Surgical · Observational
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.
A prospective, non-interventional, multi-center, post market clinical study.
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
This study's planned enrollment of 1,250 is above the median of 200 across 37 observational studies indexed under Genital Diseases, Female.
Browse Genital Diseases, Female studies →Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with gynecological disease that may be treated by surgical intervention.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery
Device: Robotic-assisted surgery (da Vinci)
Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery
Device: Non-da Vinci Surgery
Robotic-assisted surgery (da Vinci)
Non-da Vinci Surgery
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.
Time frame: 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
Time frame: 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
Time frame: 30 days
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days
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Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Feb 2028, 52 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Dec 2027 → Feb 2028 and completion Mar 2028 → Jul 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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