ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy

NCT ID: NCT05496244

Last Updated: 2023-06-15

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2030-12-31

Brief Summary

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Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy

Detailed Description

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A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

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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Epidemiological Section

Consecutive enrollment of patients with indications of interest

No interventions assigned to this group

Observational Section

Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery

Laparoscopy

Intervention Type DEVICE

Laparoscopic surgery

Robotic-assisted surgery

Intervention Type DEVICE

Robotic-assisted surgery

Interventions

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Laparoscopy

Laparoscopic surgery

Intervention Type DEVICE

Robotic-assisted surgery

Robotic-assisted surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is willing to participate and to comply with the study procedures
* Patient present with gynecological disease that may be treated with surgical intervention

Exclusion Criteria

* Life expectancy for less than 1 year
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, Germany

Vincent Lavoué, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

CHU de Rennes, France

Other Identifiers

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1.0

Identifier Type: -

Identifier Source: org_study_id

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