Status:

COMPLETED

Research on the Effectiveness and Safety of Remote Control of Domestic Surgical Robot System for Urinary Surgery

Lead Sponsor:

The Affiliated Hospital of Qingdao University

Conditions:

Renal Cell Carcinoma

Adrenal Tumor

Eligibility:

All Genders

18-65 years

Phase:

EARLY_PHASE1

Brief Summary

One-arm clinical trial was adopted in this study. The surgeon performed remote urological surgery for patients through domestically produced "MicroHand" surgical robot system (Shandong Weigao Co., Ltd...

Detailed Description

Objective: This clinical trial aims to evaluate the efficacy and safety of telesurgery for patients with tumors of the urinary system using Chinese independently developed "MicroHand" Surgical Robot S...

Eligibility Criteria

Inclusion

  • ASA class I-III
  • BMI: 18-30Kg/m2
  • patients with Robson Stage I or II renal cell carcinoma that need radical nephrectomy
  • patients with nonfunctioning kidney that need radical nephrectomy
  • patients with adrenal tumor that need adrenalectomy

Exclusion

  • women during pregnancy or lactation period
  • patients with uncontrolled hypertension
  • patients with a history of epilepsy or psychosis
  • patients with severe cardiovascular disease (NYHA, grade III-IV)
  • patients with cerebrovascular disease (CVD)
  • patients with other diseases that cannot tolerate surgery

Key Trial Info

Start Date :

February 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2021

Estimated Enrollment :

47 Patients enrolled

Trial Details

Trial ID

NCT04804163

Start Date

February 27 2021

End Date

December 30 2021

Last Update

February 16 2022

Active Locations (1)

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1

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266003