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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Gynecological Surgery

Treatments

Device: The system Kymerax
Procedure: Surgical procedure with the system Kymerax

Study type

Interventional

Funder types

Other

Identifiers

NCT01953627
2012-A00757-36
2012-21 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Surgical procedure with the system Kymerax
Experimental group
Treatment:
Device: The system Kymerax
Procedure: Surgical procedure with the system Kymerax

Trial contacts and locations

1

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Central trial contact

aubert AGOSTINI

Data sourced from clinicaltrials.gov

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