Clinical trial NCT06598085: Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery
Official title: Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Endometrial Cancer
Keywords: Cervical Cancer
Endometrial Cancer
Lead sponsor: Cornerstone Robotics
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The trial was designed using a prospective, single-centre, single-group target value approach.

For subjects who intend to undergo gynaecological surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.

To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery , and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical non-referral rate
timeFrame: During the surgery
Secondary outcomes:
measure: The surgeon's operating time
timeFrame: During the surgery
measure: Intraoperative blood loss
timeFrame: During the surgery
measure: Length of postoperative stay
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: ShenZhen
country: China
facility: Cornerstone Robotics
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: JiangTao Fan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tse 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.
citation: Pugin 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.