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

NCT06587152 | Enrolling By Invitation

• 1 other identifier: F-00359-002
• Study Type: interventional
• Target: 60
• 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 in general, gynaecological and thoracic surgical procedures.

Conditions

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

Keywords

distal gastric cancer; radical surgery; colorectal cancer; oesophageal cancer; hepatectomy; radical hysterectomy

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 (4)

• The surgeon's operating time

  during the surgery

• Length of postoperative stay

  up to 12 weeks

• Intraoperative blood loss

  during the surgery

• Length of stay

  The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.

Study Arms (1)

Robot-assisted surgery

EXPERIMENTAL

Robot-assisted thoraco-laparoscopic esophagectomy

Procedure: Robot-assisted surgery

Interventions

Robot-assisted surgery PROCEDURE

Surgery with the Cornerstone Surgical Robot.

Robot-assisted surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• 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).
• 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.

Sponsors & Collaborators

• Cornerstone Robotics: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

• 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.

  PMID: 25670040 BACKGROUND

• 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.

  PMID: 33299282 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms; Esophageal Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiujun Cai, MD

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

  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: August 8, 2024
• First Posted: September 19, 2024
• Study Start: January 22, 2024
• Primary Completion: September 12, 2024
• Study Completion: February 18, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)