Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

NCT ID: NCT01953627

Last Updated: 2014-07-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.

Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.

Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.

Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.

Detailed Description

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Conditions

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Gynecological Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical procedure with the system Kymerax

Group Type EXPERIMENTAL

Surgical procedure with the system Kymerax

Intervention Type PROCEDURE

The system Kymerax

Intervention Type DEVICE

Interventions

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Surgical procedure with the system Kymerax

Intervention Type PROCEDURE

The system Kymerax

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient requiring a following surgical procedure realized usually by coelioscopy:

Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis

Exclusion Criteria

* Patient refusing to participate in the study
* Patient understanding French.
* Minor waits
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

aubert AGOSTINI

Role: PRINCIPAL_INVESTIGATOR

AP HM

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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aubert AGOSTINI

Role: CONTACT

Facility Contacts

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AUBERT AGOSTINI

Role: primary

Other Identifiers

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2012-21

Identifier Type: OTHER

Identifier Source: secondary_id

2012-A00757-36

Identifier Type: -

Identifier Source: org_study_id

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