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Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

NCT03093675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-03-28

No results posted yet for this study

Summary

This is a prospective, single-center clinical trial. One hundred and fifty patients affected by adnexal and uterine diseases will be recruited to undergo treatment with robotic assisted laparoscopic procedures using the innovative TELELAP ALF-X Endoscopic Robotic Surgical System with the primary objective of assessing the feasibility, efficacy and safety of this approach.

Conditions

  • Adnexal Diseases
  • Uterine 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.

Sponsors & Collaborators

  • SOFAR S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giovanni Scambia, Professor · Department for the Protection of Health of Women, Newborns, Children and Adolescents A. Gemelli University Polyclinic Catholic University of the Sacred Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-23
Primary Completion
2014-12-09
Completion
2014-12-09

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093675 on ClinicalTrials.gov