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

Gynecological Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01953627
• Other study ID #: 2012-A00757-36
• Secondary ID: 2012-21
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2012
• Last updated: July 23, 2014
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: aubert AGOSTINI
• Email: aubert.agostini[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gynecological Surgery

Intervention

Procedure:
• Surgical procedure with the system Kymerax

Device:
• The system Kymerax

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of Kymerax systemerax		18 months	No