Clinical trial · Interventional
Sirius in Gynaecological Laparoscopic Surgery
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gynaecological laparoscopic surgery (Sirius System) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gynaecological laparoscopic surgery
- description
- Eligible women aged 18 - 70 years, regardless of parity, who need laparoscopic gynaecological surgery and who provide informed consent prior to surgery
- interventionNames
- Device: Gynaecological laparoscopic surgery (Sirius System)
Primary outcomes (1)
- measure
- To evaluate the Performance and Safety of the SIRIUS Endoscope System articulated tip.
- timeFrame
- Data will be collected during the operation and the analysis will be completed up to 1 month post-operation
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNg 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 35321072