Robotic-assisted surgery (da Vinci)
DeviceRobotic-assisted surgery (da Vinci)
NCT Number: NCT05867927
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Albertinen Krankenhaus Hamburg, Hamburg, Free and Hanseatic City of Hamburg, Germany
A prospective, non-interventional, multi-center, post market clinical study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Robotic-assisted surgery (da Vinci)
Non-da Vinci Surgery
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.
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
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
Time frame: 30 days
Descriptive analysis of patient characteristics such as age on surgery (e.g., duration of surgery, instrument usage)
Time frame: 30 days
Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation)
Time frame: 30 days
Descriptive analysis of patient characteristics such as age on complication (number of complications reported during and after the surgery)
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)
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
Time frame: 12 months
Describe the number disease recurrence and re-operation at final patient follow-up; descriptive analysis will be performed
Time frame: 30 days
Describe the number conversion per procedure and patient characteristics; descriptive analysis will be performed
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
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
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
Contact information is provided by the study sponsor or research team.
Peter Appenrodt
CONTACT
Petra Kremer
CONTACT
Intuitive Surgical
Industry
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications - A Prospective, Non-interventional, Multi-center, Post Market Clinical Study
Acronym: GENERATE
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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