Evaluating a new robotic system for lung cancer surgery

Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery: A Prospective, Single Center Study

This study is testing a new robotic system for lung cancer surgery to see if it works better and is safer than traditional surgery methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06286150 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy and safety of a single-port surgical robot system specifically designed for thoracic surgery in patients with lung cancer. The robotic system offers advanced features such as a 3D high-definition visual system and flexible instruments, which may enhance surgical precision. Conducted at a single center, the study aims to determine how well this innovative approach performs compared to traditional methods. Participants will undergo endoscopic surgical treatment for lung segment or lobe resection, with careful monitoring throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who require endoscopic surgical treatment for lung cancer and are classified as ASA I-III.

Not a fit: Patients with severe comorbidities or a history of thoracic surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this robotic system could improve surgical outcomes and recovery times for lung cancer patients.

How similar studies have performed: While robotic surgery has shown promise in various fields, the specific application of a single-port system for thoracic surgery is relatively novel and has not been extensively tested in China.

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.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Jianxing He, M.D.

Conditions: Lung Cancer, surgical robot system, efficacy, safety, thoracic surgery