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

NCT ID: NCT05867927

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-25

Study Completion Date

2028-03-31

Brief Summary

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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

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

Conditions

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GYN Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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da Vinci Patients

Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery

Robotic-assisted surgery (da Vinci)

Intervention Type DEVICE

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

Non-da Vinci Surgery

Intervention Type DEVICE

Non-da Vinci Surgery

Interventions

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Robotic-assisted surgery (da Vinci)

Robotic-assisted surgery (da Vinci)

Intervention Type DEVICE

Non-da Vinci Surgery

Non-da Vinci Surgery

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingolf Juhasz-Böss, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Freiburg

Locations

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Albertinen Krankenhaus Hamburg

Hamburg, Hamburg, Germany

Site Status RECRUITING

St. Josefs-Hospital Wiesbaden

Wiesbaden, Hesse, Germany

Site Status RECRUITING

Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie

Berlin, , Germany

Site Status RECRUITING

Augusta-Kranken-Anstalt Bochum

Bochum, , Germany

Site Status RECRUITING

Sana Kliniken Coburg

Coburg, , Germany

Site Status RECRUITING

St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, , Germany

Site Status TERMINATED

Universitätsklinikum Essen

Essen, , Germany

Site Status NOT_YET_RECRUITING

Agaplesion Markus Krankenhaus Frankfurt am Main

Frankfurt am Main, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg - Klinik für Frauenheilkunde

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status RECRUITING

St. Ansgar Krankenhaus Höxter

Höxter, , Germany

Site Status RECRUITING

Universitätsklinikum Kiel

Kiel, , Germany

Site Status RECRUITING

Klinikum Nürnberg Nord / Klinik für Frauenheilkunde

Nuremberg, , Germany

Site Status RECRUITING

Helios Kliniken Schwerin

Schwerin, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen - Frauenklinik

Tübingen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Countries

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Germany

Central Contacts

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Petra Kremer

Role: CONTACT

+49 151 62679136

Peter Appenrodt

Role: CONTACT

+49 173 2043740

Facility Contacts

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Rüdiger Klapdor, Prof. Dr.

Role: primary

Bettina Blau-Schneider, Dr.

Role: primary

+49 611 177 1502

Mustafa Zefal Muallem, Prof. Dr.

Role: primary

Matthias Losch, Dr.

Role: primary

Harald-Hans Altmann, Dr.

Role: primary

+49 9561 99390

Stefanos Moukas, Dr.

Role: primary

+49 201 723 85647

Marc Thill, Prof. Dr.

Role: primary

Markus Hübner, Prof. Dr.

Role: primary

Zaher Alwafai, Dr.

Role: primary

+49 3834 86 6500

Stefan Bettin, Dr.

Role: primary

Ibrahim Alkatout, Prof. Dr.

Role: primary

Dimitrios Bolovis, Prof. Dr.

Role: primary

Nicole Stahl

Role: primary

Other Identifiers

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114363C

Identifier Type: -

Identifier Source: org_study_id

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