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RecruitingNCT06246617Updated Feb 7, 2024

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

An interventional study of da Vinci SP Surgical System for Single-Port Thoracic Surgeries in da Vinci SP Surgical System and Thoracic Surgery, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Oct 2023, registered Jan 2024).
  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • da Vinci SP Surgical System
  • Thoracic Surgery
03

In context

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Arm 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.

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

Interventions

  • Deviceda Vinci SP Surgical System for Single-Port Thoracic Surgeries

    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.

06

What researchers measure

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

    Time frame: intraoperative

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06246617
Lead sponsor
Ruijin Hospital
Collaborators
Intuitive Surgical
Responsible party
Sponsor
First posted
Feb 7, 2024
Start date
Oct 25, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Jan 28, 2025 (estimated)
Last update
Feb 7, 2024

Study contacts

Hecheng Li
Contact
lhc11863@rjh.com.cn
+862164370045
Chengqiang Li
Contact
lcq12305@rjh.com.cn
13524282905

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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