NCT05048407

Brief 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.

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
30

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable ovarian-cancer

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 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

September 8, 2021

Last Update Submit

November 15, 2023

Conditions

Ovarian CancerCervical CancerGynecologic Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the Performance and Safety of the SIRIUS Endoscope System articulated tip.

    The performance and safety of the endoscope system will be evaluated based on the outcome of the operation, in terms of patient blood lost and duration of the operation are comparable with the use of other conventional endoscope systems.

    Data will be collected during the operation and the analysis will be completed up to 1 month post-operation

Secondary Outcomes (1)

  • To assess the amount of time of straight and bending positions of SIRIUS Endoscope System articulated tip. To evaluate the events of device deficiency and/or malfunctions of SIRIUS Endoscope System. To evaluate the Safety of SIRIUS Endoscope System

    Data will be collected during the operation and it will be completed upon the completion of the operation

Study Arms (1)

Gynaecological laparoscopic surgery

EXPERIMENTAL

Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery

Device: Gynaecological laparoscopic surgery (Sirius System)

Interventions

Gynaecological laparoscopic surgery (Sirius System)DEVICE

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.

Gynaecological laparoscopic surgery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen-only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible women, 18 or older, who are planned for laparoscopic gynaecological surgery and willing to provide informed consent prior to surgery

You may not qualify if:

  • Patient is pregnant, or planning on becoming pregnant
  • Obese patients (BMI \>35)
  • Patient with known contraindication(s) to Laparoscopic Gynecological Surgery
  • Patient with operations planned for longer than 4 hours
  • Subjects are considered ineligible for the study as judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gleneagles Hospital Hong Kong

Wong Chuk Hang, Hong Kong

RECRUITING

Related Publications (1)

  • Ng TY, Ngu SF, Kam TYD, Ng SY, Lo PLB. First in-human trial and prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynecology: an IDEAL stage 1 and 2a study. BMJ Surg Interv Health Technol. 2022 Mar 4;4(1):e000117. doi: 10.1136/bmjsit-2021-000117. eCollection 2022.

    PMID: 35321072DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine Diseases

Study Officials

  • Tong Yow Ng, MD

    Gleneagles Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benny Lo, PhD

CONTACT

+852 64785586b.lo@precisionrobotics.com

Ruchita Mehta, MS

CONTACT

+852 70734437R.Mehta@precisionrobotics.com

Study Design

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

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

May 30, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)