---
title: GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
nct_id: NCT05867927
overall_status: RECRUITING
sponsor: Intuitive Surgical
study_type: OBSERVATIONAL
primary_condition: GYN Disorders
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05867927.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05867927"
ct_last_update_post_date: 2026-05-05
last_seen_at: "2026-05-12T07:02:46.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

**Official Title:** GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study

**NCT ID:** [NCT05867927](https://clinicaltrials.gov/study/NCT05867927)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1250
- **Lead Sponsor:** Intuitive Surgical
- **Conditions:** GYN Disorders
- **Start Date:** 2023-10-25
- **Completion Date:** 2028-03
- **CT.gov Last Update:** 2026-05-05

## 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.

## Detailed Description

A prospective, non-interventional, multi-center, post market clinical study.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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

- **Robotic-assisted surgery (da Vinci)** (DEVICE) — Robotic-assisted surgery (da Vinci)
- **Non-da Vinci Surgery** (DEVICE) — Non-da Vinci Surgery

## Primary Outcomes

- **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

## 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)_

## Locations (15)

- Albertinen Krankenhaus Hamburg, Hamburg, Free and Hanseatic City of Hamburg, Germany — _RECRUITING_
- St. Josefs-Hospital Wiesbaden, Wiesbaden, Hesse, Germany — _RECRUITING_
- Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie, Berlin, Germany — _RECRUITING_
- Augusta-Kranken-Anstalt Bochum, Bochum, Germany — _RECRUITING_
- Sana Kliniken Coburg, Coburg, Germany — _RECRUITING_
- St. Elisabeth-Krankenhaus Köln-Hohenlind, Cologne, Germany — _TERMINATED_
- Universitätsklinikum Essen, Essen, Germany — _RECRUITING_
- Agaplesion Markus Krankenhaus Frankfurt am Main, Frankfurt am Main, Germany — _RECRUITING_
- Universitätsklinikum Freiburg - Klinik für Frauenheilkunde, Freiburg im Breisgau, Germany — _RECRUITING_
- Universitätsmedizin Greifswald, Greifswald, Germany — _RECRUITING_
- St. Ansgar Krankenhaus Höxter, Höxter, Germany — _RECRUITING_
- Universitätsklinikum Kiel, Kiel, Germany — _RECRUITING_
- Klinikum Nürnberg Nord / Klinik für Frauenheilkunde, Nuremberg, Germany — _RECRUITING_
- Helios Kliniken Schwerin, Schwerin, Germany — _RECRUITING_
- Universitätsklinikum Tübingen - Frauenklinik, Tübingen, Germany — _ACTIVE_NOT_RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.albertinen krankenhaus hamburg|hamburg|free and hanseatic city of hamburg|germany` — added _(2026-05-12)_
- `locations.st. josefs-hospital wiesbaden|wiesbaden|hesse|germany` — added _(2026-05-12)_
- `locations.charité - universitätsmedizin berlin - klinik für gynäkologie|berlin||germany` — added _(2026-05-12)_
- `locations.augusta-kranken-anstalt bochum|bochum||germany` — added _(2026-05-12)_
- `locations.sana kliniken coburg|coburg||germany` — added _(2026-05-12)_
- `locations.st. elisabeth-krankenhaus köln-hohenlind|cologne||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum essen|essen||germany` — added _(2026-05-12)_
- `locations.agaplesion markus krankenhaus frankfurt am main|frankfurt am main||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum freiburg - klinik für frauenheilkunde|freiburg im breisgau||germany` — added _(2026-05-12)_
- `locations.universitätsmedizin greifswald|greifswald||germany` — added _(2026-05-12)_
- `locations.st. ansgar krankenhaus höxter|höxter||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum kiel|kiel||germany` — added _(2026-05-12)_
- `locations.klinikum nürnberg nord / klinik für frauenheilkunde|nuremberg||germany` — added _(2026-05-12)_
- `locations.helios kliniken schwerin|schwerin||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum tübingen - frauenklinik|tübingen||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05867927.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05867927*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*