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

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.

Study Overview

• Status: Recruiting
• Conditions: GYN Disorders
• Intervention / Treatment: Device: Robotic-assisted surgery (da Vinci); Device: Non-da Vinci Surgery

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1250

Contacts and Locations

• Study Contact: Name: Petra Kremer; Phone Number: +49 151 62679136; Email: petra.kremer@intusurg.com
• Study Contact Backup: Name: Peter Appenrodt; Phone Number: +49 173 2043740; Email: peter.appenrodt@intusurg.com

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
    • Contact: Mustafa Zefal Muallem, Prof. Dr.
  • Bochum, Germany, 44791
    • Recruiting
    • Augusta-Kranken-Anstalt Bochum
    • Contact: Matthias Losch, Dr.
  • Coburg, Germany, 96450
    • Recruiting
    • Sana Kliniken Coburg
    • Contact: Harald-Hans Altmann, Dr.; Phone Number: +49 9561 99390; Email: harald-hans.altmann@regiomed-kliniken.de
  • Cologne, Germany, 50935
    • Terminated
    • St. Elisabeth-Krankenhaus Köln-Hohenlind
  • Essen, Germany, 45147
    • Recruiting
    • Universitatsklinikum Essen
    • Contact: Stefanos Moukas, Dr.; Phone Number: +49 201 723 85647; Email: studien.frauenklinik@uk-essen.de
  • Frankfurt am Main, Germany, 60431
    • Recruiting
    • Agaplesion Markus Krankenhaus Frankfurt am Main
    • Contact: Marc Thill, Prof. Dr.
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Universitätsklinikum Freiburg - Klinik für Frauenheilkunde
    • Contact: Markus Hübner, Prof. Dr.
  • Greifswald, Germany, 17475
    • Recruiting
    • Universitätsmedizin Greifswald
    • Contact: Zaher Alwafai, Dr.; Phone Number: +49 3834 86 6500; Email: zaher.alwafai@med.uni-greifswald.de
  • Höxter, Germany, 37671
    • Recruiting
    • St. Ansgar Krankenhaus Höxter
    • Contact: Stefan Bettin, Dr.; Email: S.Bettin@khwe.de
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Kiel
    • Contact: Ibrahim Alkatout, Prof. Dr.
  • Nuremberg, Germany, 90419
    • Recruiting
    • Klinikum Nürnberg Nord / Klinik für Frauenheilkunde
    • Contact: Dimitrios Bolovis, Prof. Dr.
  • Schwerin, Germany, 19055
    • Recruiting
    • Helios Kliniken Schwerin
    • Contact: Nicole Stahl
  • Tübingen, Germany, 72076
    • Active, not recruiting
    • Universitätsklinikum Tübingen - Frauenklinik
  • Free and Hanseatic City of Hamburg
    • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22457
      • Recruiting
      • Albertinen Krankenhaus Hamburg
      • Contact: Rüdiger Klapdor, Prof. Dr.
  • Hesse
    • Wiesbaden, Hesse, Germany, 65189
      • Recruiting
      • St. Josefs-Hospital Wiesbaden
      • Contact: Bettina Blau-Schneider, Dr.; Phone Number: +49 611 177 1502; Email: bblau-schneider@joho.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with gynecological disease that may be treated by surgical intervention.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
da Vinci Patients; Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery	Device: Robotic-assisted surgery (da Vinci); 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	Device: Non-da Vinci Surgery; Non-da Vinci Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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	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	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	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	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	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	30 days

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Ingolf Juhasz-Böss, Prof. Dr., Universitatsklinikum Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Surgical Procedures, Operative; Technology, Industry, and Agriculture; Automation; Technology; Surgery, Computer-Assisted; Robotics; Robotic Surgical Procedures
• Other Study ID Numbers: 114363C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes