Evaluating the safety and performance of a robotic surgical system for thoracic surgeries
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Thoracic Surgeries
NA · Ruijin Hospital · NCT06246617
This study is testing a new robotic surgery system to see if it is safe and effective for patients in China undergoing thoracic surgeries like lung and esophagus operations.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06246617 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the clinical performance and safety of the da Vinci SP Surgical System, a single-port robotic system, in real-world thoracic surgeries. It involves patients who are undergoing procedures such as pulmonary lobectomy, mediastinal tumor resection, and esophageal cancer surgery using this advanced robotic technology. The study will gather real-world evidence to support the clinical application of the system specifically within the Chinese population. Participants will be monitored for outcomes related to safety and effectiveness during their surgeries.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for pulmonary lobectomy, segmentectomy, mediastinal tumor resection, or radical esophageal cancer surgery using the da Vinci SP Surgical System.
Not a fit: Patients with contraindications for single-port robotic surgery or those deemed inappropriate for the study by investigators may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and safety for patients undergoing thoracic surgeries using robotic assistance.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot; 2. Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC). Exclusion Criteria: * 1. Patients with missing data on the primary endpoint in retrospective cases; 2. Subjects having any contraindications of single-port robot surgery; 3. The intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. Patients who are considered inappropriate to participate in this study by investigator.
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Hecheng Li
- Email: lhc11863@rjh.com.cn
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: da Vinci SP Surgical System, Thoracic Surgery