Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery

NCT07382635 | Not Yet Recruiting

• 1 other identifier: F-00300-003
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery

Conditions

Colorectal Cancer; Esophageal Cancer; Hepatectomy; Radical Hysterectomy

Keywords

distal gastric cancer; radical surgery; colorectal 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 (3)

• The surgeon's operating time

  during the surgery

• 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.

Interventions

Robot-assisted surgery DEVICE

Surgery with the Cornerstone Surgical Robot.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).

You may qualify if:

• Age ≥ 18 and ≤ 80 years;
• Patients confirmed by investigators eligible for surgeries in urology (e.g., partial nephrectomy (transperitoneal/retroperitoneal), radical prostatectomy, pyeloplasty, etc.), general surgery (e.g., distal/radical total gastrectomy for gastric cancer, radical resection for colorectal cancer, hepatectomy/splenectomy, etc.), gynecology (e.g., radical hysterectomy plus pelvic lymphadenectomy, etc.) and thoracic surgery (e.g., segmental/lobectomy, radical esophagectomy, etc.).
• Subjects voluntarily participate in the clinical trial, and subjects or their guardians give informed consent and sign the informed consent form.
• Willing to cooperate with and complete trial follow-ups and relevant examinations.

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).
• Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

Sponsors & Collaborators

• Cornerstone Robotics: lead

Related Publications (1)

• Lai EC, Tang CN. Long-term Survival Analysis of Robotic Versus Conventional Laparoscopic Hepatectomy for Hepatocellular Carcinoma: A Comparative Study. Surg Laparosc Endosc Percutan Tech. 2016 Apr;26(2):162-6. doi: 10.1097/SLE.0000000000000254.

  PMID: 27031650 RESULT

Related Links

• Related Info

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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share