Evaluation of a new robotic system for gynecological laparoscopic surgery
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
NA · Precision Robotics (Hong Kong) Limited · NCT05048407
This study is testing a new robotic camera system to see if it can make gynecological surgeries safer and more effective for women.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Precision Robotics (Hong Kong) Limited (industry) |
| Locations | 1 site (Wong Chuk Hang) |
| Trial ID | NCT05048407 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance and safety of the SIRIUS Endoscope System, a new robotic flexible endoscopic camera designed for minimally invasive gynecological surgeries. The system features a disposable flexible tip that allows for enhanced maneuverability and a wider field of view compared to traditional laparoscopes. The study is a single-arm prospective trial involving women aged 18 and older who are scheduled for laparoscopic gynecological procedures. The aim is to assess the effectiveness and safety of this innovative technology in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older who are scheduled for laparoscopic gynecological surgery.
Not a fit: Patients who are pregnant, obese (BMI > 35), or have contraindications to laparoscopic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could lead to safer and more effective minimally invasive surgeries for patients with gynecological cancers.
How similar studies have performed: Previous studies have shown promising results with similar robotic systems, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible women, 18 or older, who are planned for laparoscopic gynaecological surgery and willing to provide informed consent prior to surgery Exclusion Criteria: 1. Patient is pregnant, or planning on becoming pregnant 2. Obese patients (BMI \>35) 3. Patient with known contraindication(s) to Laparoscopic Gynecological Surgery 4. Patient with operations planned for longer than 4 hours 5. Subjects are considered ineligible for the study as judged by the investigator.
Where this trial is running
Wong Chuk Hang
- Gleneagles Hospital Hong Kong — Wong Chuk Hang, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Tong Yow Ng, MD — Gleneagles Hospital
- Study coordinator: Benny Lo, PhD
- Email: b.lo@precisionrobotics.com
- Phone: +852 64785586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Cervical Cancer, Gynecologic Cancer