Clinical trial · Interventional
Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery
NCT06598085CI-TRIAL-00080693unknownN/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)
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use ingynaecological surgical procedures.
Conditions
Conditions (2)
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 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot-assisted surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robot-assisted surgery
- description
- Robot-assisted laparoscopic wide total hysterectomy
- interventionNames
- Device: Robot-assisted surgery
Primary outcomes (1)
- measure
- Surgical non-referral rate
- timeFrame
- During the surgery
- description
- Surgical untransferred is defined as not converted from an experimental medical device assisted method to another surgical device control system assisted, laparoscopic surgery or open surgery.
Secondary outcomes (3)
- measure
- The surgeon's operating time
- timeFrame
- During the surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 and ≤ 80 years; * Body Mass Height Index (BMI) 18\<BMI\<30kg/㎡; * Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery; * Written informed consent. Exclusion Criteria: * Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.); * With other malignancies or a previous history of other malignancies. * Preoperative imaging suggests that the tumour has distant metastases. * The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment. * Severe bleeding tendencies or coagulopathic disorders. * With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders. * Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids). * With severe allergies and suspected or established alcohol, drug or substance addiction. * Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
References
Publications (2)
- BACKGROUNDTse KY, Ngan HYS, Lim PC. Robot-assisted gynaecological cancer surgery-complications and prevention. Best Pract Res Clin Obstet Gynaecol. 2017 Nov;45:94-106. doi: 10.1016/j.bpobgyn.2017.04.005. Epub 2017 Apr 23. PMID 28528932
- BACKGROUNDPugin F, Bucher P, Morel P. History of robotic surgery: from AESOP(R) and ZEUS(R) to da Vinci(R). J Visc Surg. 2011 Oct;148(5 Suppl):e3-8. doi: 10.1016/j.jviscsurg.2011.04.007. Epub 2011 Oct 4. No abstract available. PMID 21974854