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NCT Number: NCT05867927

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Albertinen Krankenhaus Hamburg, Hamburg, Free and Hanseatic City of Hamburg, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-assisted surgery (da Vinci)

Device

Robotic-assisted surgery (da Vinci)

Non-da Vinci Surgery

Device

Non-da Vinci Surgery

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Investigate the impact of patient characteristics on surgery

    Time frame: 30 days

    Descriptive analysis of patient characteristics such as age on surgery (e.g., duration of surgery, instrument usage)

  2. Investigate the impact of patient characteristics on clinical outcome

    Time frame: 30 days

    Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation)

  3. Investigate the impact of patient characteristics on complications

    Time frame: 30 days

    Descriptive analysis of patient characteristics such as age on complication (number of complications reported during and after the surgery)

  4. Describe the impact from surgery to the patient's quality of life and function

    Time frame: 12 months

    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)

  5. Describe the number of Intuitive instruments used per procedure and patient characteristics

    Time frame: 30 days

    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

  6. Describe the number of disease recurrence and re-operation at final patient follow-up

    Time frame: 12 months

    Describe the number disease recurrence and re-operation at final patient follow-up; descriptive analysis will be performed

  7. Describe the number of conversion per procedure and patient characteristics

    Time frame: 30 days

    Describe the number conversion per procedure and patient characteristics; descriptive analysis will be performed

  8. 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 surgical times, descriptive analysis will be performed on the surgical times (duration of surgery) per treating surgeon

  9. 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 clinical outcome; descriptive analysis will be performed, e.g., on number of re-operation or re-hospitalization per treating surgeon

  10. Describe the impact of surgeon experience on complications (number of events per surgeon)

    Time frame: 30 days

    Describe the impact of surgeon experience on complications; descriptive analysis will be performed on number of adverse events per treating surgeon

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Appenrodt

CONTACT

[email protected]

+49 173 2043740

Petra Kremer

CONTACT

[email protected]

+49 151 62679136

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Acronym: GENERATE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 22, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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