Valuate the Clinical Performance and Safety of da Vinci SP Surgical System

NCT06246617 | Unknown FDA Device

• 1 other identifier: RTS-020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted thoracic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

Conditions

da Vinci SP Surgical System; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative conversion rate

  Intraoperative conversion rate = number of subjects with intraoperative conversion/total number of subjects ×100%. The intraoperative conversion is defined as conversion to other procedures (including but not limited to traditional laparoscopic surgeries, other robot-assisted surgeries, open surgeries and so on) for various reasons during surgery

  intraoperative

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

Device: da Vinci SP Surgical System for Single-Port Thoracic Surgeries

Interventions

da Vinci SP Surgical System for Single-Port Thoracic Surgeries DEVICE

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.

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Intuitive Surgical: collaborator

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

• Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161.

  PMID: 40658465 DERIVED

Central Study Contacts

Hecheng Li

CONTACT

+862164370045; lhc11863@rjh.com.cn

Chengqiang Li

CONTACT

13524282905; lcq12305@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: October 25, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 28, 2025
• Last Updated: February 7, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)