Clinical trial NCT06587152: Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
Official title: Clinical Trial to Evaluate the Efficacy and Safety of Endoscopy System for General Surgery, Gynecology and Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Cornerstone Robotics
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Surgical non-referral rate
timeFrame: during the surgery
Secondary outcomes:
measure: The surgeon's operating time
timeFrame: during the surgery
measure: Length of postoperative stay
timeFrame: up to 12 weeks
measure: Intraoperative blood loss
timeFrame: during the surgery
measure: Length of stay
timeFrame: The patient's total number of days from the day of surgery to discharge was recorded 30 days postoperatively.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: President of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
name: Xiujun Cai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.