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Trial Title:
Clinical Trial Protocol to Evaluate the Efficacy and Safety of Laparoscopic Surgical Systems for Gynaecological Surgery
NCT ID:
NCT06598085
Condition:
Cervical Cancer
Endometrial Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Conditions: Keywords:
Cervical Cancer
Endometrial Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
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
ingynaecological surgical procedures.
Detailed description:
The trial was designed using a prospective, single-centre, single-group target value
approach.
For subjects who intend to undergo gynaecological 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 , and to evaluate the
efficacy and safety of the experimental medical device in the surgical treatment
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 and ≤ 80 years;
- Body Mass Height Index (BMI) 18
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cornerstone Robotics
Address:
City:
ShenZhen
Zip:
518000
Country:
China
Start date:
July 1, 2024
Completion date:
January 20, 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/NCT06598085
https://pubmed.ncbi.nlm.nih.gov/28528932/
http://pubmed.ncbi.nlm.nih.gov/21974854/
