CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
TELELAP ALF-X Robotic Surgical Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093675
NCT03093675N/ACompleted
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Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study

SOFAR S.p.A.·interventional·Posted Mar 28, 2017·Updated Mar 28, 2017

In Brief

A clinical study evaluating TELELAP ALF-X Robotic Surgical System for Adnexal Diseases and Uterine Diseases. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdnexal Diseases, Uterine Diseases
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartOct 23, 2013
Primary CompletionDec 9, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.3 years ago

Interventions

TELELAP ALF-X Robotic Surgical Systemdevice

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.