Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study
|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
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)|
|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|
|Experimental: Surgical procedure with the system Kymerax||
Procedure: Surgical procedure with the system Kymerax
Device: The system Kymerax
- assessment of Kymerax systemerax [ Time Frame: 18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953627
|Contact: aubert AGOSTINIfirstname.lastname@example.org|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: AUBERT AGOSTINI email@example.com|
|Study Director:||BERNARD BELAIGUES||Assistance Publique Hopitaux De Marseille|
|Principal Investigator:||aubert AGOSTINI||AP HM|