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

September 12, 2024 updated by: Cornerstone Robotics
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • ShenZhen, Guangdong, China, 518000
        • Cornerstone Robotics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted surgery
Robot-assisted laparoscopic wide total hysterectomy
Device: Robot-assisted surgery
Surgery with the Cornerstone Surgical Robot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical non-referral rate
Time Frame: During the surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The surgeon's operating time
Time Frame: During the surgery
Operative time（minutes）
During the surgery
Intraoperative blood loss
Time Frame: During the surgery
Estimated blood loss（milliliters，ml）
During the surgery
Length of postoperative stay
Time Frame: up to 12 weeks
Total number of days the patient was in hospital from the day of surgery to discharge.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornerstone Robotics

Investigators

  • Principal Investigator: JiangTao Fan, MD, First Affiliated Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

July 29, 2024

Study Completion (Estimated)

January 20, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-00359-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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