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Efficacy and Safety of Clinical Telesurgery Using Chinese Independently Developed Surgical Robot System

NCT04570176 · The Affiliated Hospital of Qingdao University · Updated 16 Feb 2022

What is being tested
adrenalectomy for adrenal adenoma
For
Renal Cell Carcinoma; Bladder Cancer; Adrenal Tumor
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 65 years. About 1 people. The full rules are on the registry page.
Where
China
When
Starts or started 27 Aug 2020, ends 30 Nov 2021. Registered 30 Sept 2020.
Results
None posted yet.

In the researchers' words

One-arm clinical trial was adopted in this study. The surgeons performed remote urological surgery for patients through domestically produced "MicroHand" surgical robot system (Shandong Weigao Co., Ltd). The "MicroHand" surgical robot system consists of two physically separated subsystems named the "surgeon console" and "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 (one for the endoscopic camera and the other two for surgical instruments). The surgeon console (based in Qingdao) takes the surgeon's input and translates it into a control signal. After network transmission, the patient side cart (based in Anshun) translates the control signal into actual instrument manipulation. The 3D images captured by the endoscopic camera were simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart were transmitted through a 5G network. The safety and effectiveness of the robotic system in remote clinical diagnosis and treatment were verified by the main judgment criterion and secondary judgment criterion. Six patients…
ClinicalTrials.gov, NCT04570176

Sites

  • The Affiliated Hospital of Qingdao UniversityQingdao, Shandong, China