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

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ClinicalTrials.gov Identifier: NCT01953627
Recruitment Status : Unknown
Verified July 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : October 1, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gynecological Surgery Procedure: Surgical procedure with the system Kymerax Device: The system Kymerax Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
Study Start Date : October 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Surgical procedure with the system Kymerax Procedure: Surgical procedure with the system Kymerax
Device: The system Kymerax



Primary Outcome Measures :
  1. assessment of Kymerax systemerax [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953627


Contacts
Contact: aubert AGOSTINI aubert.agostini@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: AUBERT AGOSTINI       aubert.agostini@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille
Principal Investigator: aubert AGOSTINI AP HM

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01953627     History of Changes
Other Study ID Numbers: 2012-A00757-36
2012-21 ( Other Identifier: AP HM )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014