The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery

Summary

A single-arm clinical trial was designed in this study. The surgeon will perform urological telesurgery for patients using Chinese domestically produced "MicroHand S" surgical robot system. The "MicroHand S" surgical robot system consists of two physically separated subsystems named the "surgeon console" and the "patient side cart". The surgeon console includes a stereo image viewer, two master manipulators, a control panel and several foot pedals. The patient side cart includes a passive arm that can slide in the up-down direction and be adjusted forward and backward, a swivel head that can rotate around the vertical axis, and three slave arms. In addition, surgical instruments and sterile bags are the essential accessories for the "patient side cart". The principle of the telesurgery is as follows: the surgeon console takes the surgeon's input and translates manipulation into a control signal. After network transmission, the signals will be received by the patient side cart and will be used to control the slave robot to manipulate the instruments to perform the operation within the patient's cavity. The 3D images captured by the endoscopic camera will be simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart will be transmitted through a 5G network or other advanced network networking scheme. The surgeon remotely manipulates the slave arms and performs surgeries for patients in remote areas. The safety and efficacy of the robot system in remote clinical treatment will be verified by the primary and the secondary evaluation criteria. One hundred patients with urological diseases will be enrolled in the clinical trial.

Primary evaluation criterion:

The success rate of the surgery. Surgery success is defined as that all surgeries are performed remotely and safely without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery.

Secondary evaluation criteria:

Operative time, blood loss, postoperative pain, preoperative adjusting time, hospitalization time, average network latency, task load, peer recognition, anxiety index.

Patient enrollment:

This experiment aims to investigate the safety and effectiveness of the domestic robot system in clinical urological surgery under the current network networking scheme. It is planned that 100 patients with urinary system diseases will participate in the clinical trial.

Conditions

• Renal Cell Carcinoma
• Adrenal Tumor
• Nonfunctioning Kidney
• Renal Pelvis Carcinoma
• Ureteral Tumor
• Bladder Cancer
• Prostate Cancer
• Pelvic Tumor
• Renal Cyst
• Duplex Kidney
• Renal Calculi
• Ureteral Calculi
• Ureteropelvic Junction Obstruction
• Penile Cancer

Interventions

DEVICE

telesurgery by domestic surgical robot

telesurgery of urological diseases by domestic surgical robot

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University

  lead OTHER

Principal Investigators

• Haitao Niu, PhD · The Affiliated Hospital of Qingdao University

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-05

Primary Completion

2024-03-31

Completion

2024-04-30

Countries

• China

Study Locations