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Trial Title:
Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
NCT ID:
NCT06587152
Condition:
Pathologic Stage I Gastric Cancer AJCC v8
Colorectal Cancer
Esophageal Cancer
Hepatectomy
Radical Hysterectomy
Conditions: Official terms:
Colorectal Neoplasms
Stomach Neoplasms
Conditions: Keywords:
distal gastric cancer
radical surgery
colorectal cancer
oesophageal cancer
hepatectomy
radical hysterectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Robot-assisted surgery
Description:
Surgery with the Cornerstone Surgical Robot.
Arm group label:
Robot-assisted surgery
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 and ≤ 80 years;
- Body Mass Height Index (BMI) 18
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Start date:
January 22, 2024
Completion date:
February 18, 2025
Lead sponsor:
Agency:
Cornerstone Robotics
Agency class:
Industry
Source:
Cornerstone Robotics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06587152
https://pubmed.ncbi.nlm.nih.gov/25670040/
https://pubmed.ncbi.nlm.nih.gov/33299282/
