Clinical trial NCT05867927: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GYN Disorders
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with gynecological disease that may be treated by surgical intervention.

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 criteria: 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

Primary outcomes:
measure: Number of complications related to the surgery up to 30 days
timeFrame: 30 days
measure: Describe the number of patient-reported outcomes up to 12 months
timeFrame: 12 months
measure: Characterize the treatment decision as reported by the treating physician
timeFrame: 30 days
Secondary outcomes:
measure: Investigate the impact of patient characteristics on surgery
timeFrame: 30 days
measure: Investigate the impact of patient characteristics on clinical outcome
timeFrame: 30 days
measure: Investigate the impact of patient characteristics on complications
timeFrame: 30 days
measure: Describe the impact from surgery to the patient's quality of life and function
timeFrame: 12 months
measure: Describe the number of Intuitive instruments used per procedure and patient characteristics
timeFrame: 30 days
measure: Describe the number of disease recurrence and re-operation at final patient follow-up
timeFrame: 12 months
measure: Describe the number of conversion per procedure and patient characteristics
timeFrame: 30 days
measure: Describe the impact of surgeon experience on surgical times (duration of surgery per treating surgeon)
timeFrame: 30 days
measure: Describe the impact of surgeon experience on clinical outcome (number of clinical outcomes per treating surgeon)
timeFrame: 30 days
measure: Describe the impact of surgeon experience on complications (number of events per surgeon)
timeFrame: 30 days
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden
state: Hessen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt Bochum
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus Frankfurt am Main
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus Hamburg
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
city: Köln
country: Germany
facility: St. Elisabeth-Krankenhaus Köln-Hohenlind
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord / Klinik für Frauenheilkunde
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen - Frauenklinik
Study officials:
affiliation: Universitätsklinikum Freiburg
name: Ingolf Juhasz-Böss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: