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A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

NCT05318625 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-03

No results posted yet for this study

Summary

Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.

A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.

The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System.

Conditions

Interventions

DEVICE

Gynaecological laparoscopic surgery (Sirius System)

The laparoscopic procedures were done in the usual manner. The only difference was for the study participants, the Sirius System was used in place of the usual conventional laparoscope. All other procedures and instruments including the number of ports remained the same. For every procedure using the Sirius System, a conventional laparoscope was on immediate standby to replace the Sirius System should there be an unanticipated equipment failure so that the procedure could be completed without delay.

Sponsors & Collaborators

  • Gleneagles Hospital

    collaborator OTHER

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • Precision Robotics (Hong Kong) Limited

    lead INDUSTRY

Principal Investigators

  • Tong Yow Ng, MD · Gleneagles Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

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 NCT05318625 on ClinicalTrials.gov