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

ConditionGYN Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIntuitive Surgical

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

1,250 Participants
are divided into 2 treatment groups

Sponsors and collaborators