NCT01953627

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

September 24, 2012

Last Update Submit

July 23, 2014

Conditions

Gynecological Surgery

Outcome Measures

Primary Outcomes (1)

  • assessment of Kymerax systemerax

    18 months

Study Arms (1)

Surgical procedure with the system Kymerax

EXPERIMENTAL
Procedure: Surgical procedure with the system KymeraxDevice: The system Kymerax

Interventions

Surgical procedure with the system KymeraxPROCEDURE
Surgical procedure with the system Kymerax
The system KymeraxDEVICE
Surgical procedure with the system Kymerax

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient refusing to participate in the study
  • Patient understanding French.
  • Minor waits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

  • aubert AGOSTINI

    AP HM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

aubert AGOSTINI

CONTACT

aubert.agostini@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2012

First Posted

October 1, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

FR(1)