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

GYN Disorders Clinical Trial

— GENERATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867927
• Other study ID #: 114363C
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Intuitive Surgical
• Contact: Petra Kremer
• Phone: +49 151 62679136
• Email: petra.kremer[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications Generate real-world evidence in the use of the da Vinci Xi/X Surgical Systems for gynecological indications within the German health care system.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1125
• Est. completion date: June 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• GYN Disorders

Intervention

Device:
• Robotic-assisted surgery (da Vinci)
Robotic-assisted surgery (da Vinci)
• Non-da Vinci Surgery
Non-da Vinci Surgery

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie	Berlin
Germany	Universitätsklinikum Freiburg - Klinik für Frauenheilkunde	Freiburg
Germany	Albertinen Krankenhaus Hamburg	Hamburg
Germany	St. Elisabeth-Krankenhaus Köln-Hohenlind	Köln
Germany	Klinikum Nürnberg Nord / Klinik für Frauenheilkunde	Nürnberg
Germany	Universitätsklinikum Tübingen - Frauenklinik	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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