Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 23, 2013

Primary Completion Date

December 9, 2014

Study Completion Date

December 9, 2014

Conditions
Adnexal DiseasesUterine Diseases
Interventions
DEVICE

TELELAP ALF-X Robotic Surgical System

The surgical procedures will be performed using the innovative TELELAP ALF-X robotic system, equipped with multiple independent arms. Initial entry will be through a classic open in which the arm with the video camera will be inserted. The device has four independent arms (one for the video camera and three for surgical instruments). Patients will be in the lithotomy position, supported by Allen stirrups and under general anesthesia. The uterus will be manipulated with a multi-use uterine manipulator. After having induced a pneumoperitoneum, high-definition 3D-technology optics will be inserted. Three laparoscopic instruments will be used to complete the procedure. Standard techniques will be used.

Trial Locations (1)

00168

Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart, Rome

All Listed Sponsors
lead

SOFAR S.p.A.

INDUSTRY

NCT03093675 - Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study | Biotech Hunter | Biotech Hunter