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Trial Title:
Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery
NCT ID:
NCT06286150
Condition:
Lung Cancer
Conditions: Keywords:
surgical robot system
efficacy
safety
thoracic surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Surgical robot system
Description:
SHURUI Single-port surgical robot system
Arm group label:
single-port robot group
Summary:
Robotic surgical systems have become a promising surgical assistance system, with unique
advantages such as 3D high-definition visual system, highly flexible wrist-jointed
instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied
in various fields including urology, general surgery, cardiothoracic surgery, head and
neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most
widely used robot system globally. However, the Da Vinci robot system for single-port
laparoscopic surgery has not yet been launched in China. Therefore, the investigators
conduct a prespective, single-center study to evaluate the efficacy and safety of
single-port surgical robot system in thoracic surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age between 18 and 75 years, regardless of gender.
- Patients who require endoscopic surgical treatment and have indications for lung
segment/lobe resection; for pre-trial subjects, there is no restriction on the type
of procedure, and inclusion is based on the investigator's judgment of having
indications for thoracic surgery.
- Preoperative ASA classification of I-III.
- Voluntary participation in the clinical trial and willingness to provide informed.
consent, either by the subject or their guardian.
- Willingness to cooperate and complete trial follow-up and related examinations.
Exclusion Criteria:
- Patients with a history of thoracic surgery or previous history of other malignant
tumors deemed unsuitable for inclusion by the investigator.
- Patients with severe comorbidities (cardiac, pulmonary, hepatic, cerebral, renal
diseases) or physical weakness who cannot tolerate general anesthesia or surgery.
- Patients with severe bleeding tendencies or coagulation disorders.
- Patients in the active phase of infectious diseases or with other severe
non-communicable infections.
- Patients positive for Human Immunodeficiency Virus (HIV) antibodies or syphilis
seropositive patients.
- Patients with a suspected or confirmed alcohol, drug, or substance addiction.
- Patients with a history of epilepsy, mental illness, or cognitive impairment.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the
trial period.
- Participation in other interventional clinical trials within 3 months prior to
signing the informed consent form.
- Other situations in which the investigator deems inappropriate for participation in
this clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianxing He, M.D.
Phone:
+86-20-83337792
Email:
hejx@vip.163.com
Start date:
September 15, 2023
Completion date:
July 15, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
The First Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06286150
