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A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)

NCT06082011 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-10-13

No results posted yet for this study

Summary

Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries Study purpose：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 robotic surgeries of gynecological benign and malignant tumors in the real world, providing a real world evidence for clinical application of the product in the Chinese population.

Study design：Retrospective + prospective, real-world study

English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Conditions

  • Gynecological Surgeries

Interventions

DEVICE

da Vinci SP Surgical System

Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2024-10-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082011 on ClinicalTrials.gov