Clinical trial · Interventional
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
NCT05318625CI-TRIAL-00068500unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 (2)
- measure
- General Assessment of SIRIUS Endoscope System.
- timeFrame
- Through study completion, Up to 1 year from the first to the last patients
- description
- General Assessment of SIRIUS Endoscope System, using Questionnaire- Clinical Study General Assessment of SIRIUS Endoscope System)
- measure
- SIRIUS Endoscope Articulated tip assessment.
- timeFrame
- Through study completion, Up to 1 year from the first to the last patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are planned for Laparoscopic Gynecological Surgery (LGS) * Patient is 18 years of age or older * Signed written informed consent. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.