Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery

NCT06598085 | Active Not Recruiting

• 1 other identifier: F-00359-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Endometrial Cancer

Keywords

Cervical Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Surgical non-referral rate

  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.

  During the surgery

Secondary Outcomes (3)

• The surgeon's operating time

  During the surgery

• Intraoperative blood loss

  During the surgery

• Length of postoperative stay

  up to 12 weeks

Study Arms (1)

Robot-assisted surgery

EXPERIMENTAL

Robot-assisted laparoscopic wide total hysterectomy

Device: Robot-assisted surgery

Interventions

Robot-assisted surgery DEVICE

Surgery with the Cornerstone Surgical Robot.

Robot-assisted surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cornerstone Robotics: lead

Study Sites (1)

Cornerstone Robotics

Shenzhen, Guangdong, 518000, China

Location

Related Publications (2)

• 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.

  PMID: 28528932 BACKGROUND

• 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.

  PMID: 21974854 BACKGROUND

Related Links

• Ever since the US Food and Drug Administration approval of the use of da Vinci surgical systems (Intuitive Surgical Inc., Sunnyvale, California) in gynaecology in 2005, robot-assisted surgery has been widely adopted in different countries.
• History of robotic surgery: from AESOP® and ZEUS® to da Vinci®

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• JiangTao Fan, MD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: July 29, 2024
• Study Completion: January 20, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)