Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System

NCT ID: NCT06587152

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2025-02-18

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 in general, gynaecological and thoracic surgical procedures.

Detailed Description

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

For subjects who intend to undergo general surgery, gynaecological surgery and thoracic 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 in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.

Conditions

Pathologic Stage I Gastric Cancer AJCC v8; Colorectal Cancer; Esophageal Cancer; Hepatectomy; Radical Hysterectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot-assisted surgery

Robot-assisted thoraco-laparoscopic esophagectomy

Group Type: EXPERIMENTAL

Robot-assisted surgery

Intervention Type: PROCEDURE

Surgery with the Cornerstone Surgical Robot.

Interventions

Robot-assisted surgery

Surgery with the Cornerstone Surgical Robot.

Intervention Type: PROCEDURE

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).
• Women who are pregnant or nursing an infant.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cornerstone Robotics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiujun Cai, MD

Role: PRINCIPAL_INVESTIGATOR

President of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Locations

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

References

Park JY, Ryu KW, Reim D, Eom BW, Yoon HM, Rho JY, Choi IJ, Kim YW. Robot-assisted gastrectomy for early gastric cancer: is it beneficial in viscerally obese patients compared to laparoscopic gastrectomy? World J Surg. 2015 Jul;39(7):1789-97. doi: 10.1007/s00268-015-2998-4.

Reference Type: BACKGROUND

PMID: 25670040 (View on PubMed)

Somashekhar SP, Deshpande AY, Ashwin KR, Gangasani R, Kumar R, Shetty S. Comparative Evaluation of the Short-Term Treatment Outcomes Between Open, Laparoscopic- and Robotic-Assisted Surgical Approaches for Rectal Cancer Treatment. Indian J Surg Oncol. 2020 Dec;11(4):649-652. doi: 10.1007/s13193-020-01137-z. Epub 2020 Jul 10.

Reference Type: BACKGROUND

PMID: 33299282 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/25670040/

The adoption of robotic systems for gastric cancer surgery has been proven feasible and safe; however, a benefit over the laparoscopic approach has not yet been well-documented.

https://pubmed.ncbi.nlm.nih.gov/33299282/

The open surgeries and more recently minimal invasive surgeries aided by laparoscopic or robotic approaches are employed for rectal cancer treatment procedures.

Other Identifiers

F-00359-002

Identifier Type: -

Identifier Source: org_study_id