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Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000).

NCT05025930 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-09-02

No results posted yet for this study

Summary

Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.

Conditions

  • Urologic Neoplasms

Interventions

DEVICE

endoscopic surgical instrument control system (SP1000: single-port laparoscopy)

The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.

DEVICE

endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)

The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Edge Medical Robotics CO.,LTD

    collaborator UNKNOWN

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Tianxin Lin, MD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-09-30
Completion
2023-09-30

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 NCT05025930 on ClinicalTrials.gov