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Robot-assisted Urological Surgeries Using the MicroHand S Robot

NCT05462392 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-08-02

No results posted yet for this study

Summary

A single-blinded, prospective randomized parallel controlled clinical trial is designed and will be conducted from July 2022 to November 2023 (anticipated). One hundred and thirty-six patients (anticipated) with renal cancer or bladder cancer or prostate cancer will be enrolled in this study. Those patients will be enrolled by two hospital centers and the patients will be randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, continence rate (if applicable), postoperative pain, comprehensive complication index, resident time and surgeon satisfaction were recorded. The aim of the study is to determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in urological surgeries compared with the prevalent da Vinci robot.

Conditions

Interventions

DEVICE

robot-assisted surgery

urological surgeries, such as partial nephrectomy, radical cystectomy, and radical prostatectomy was performed for patients using the Micro Hand S robot group.

DEVICE

robot-assisted surgery

urological surgeries, such as partial nephrectomy, radical cystectomy, and radical prostatectomy was performed for patients using the da Vinci robot group

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT05462392 on ClinicalTrials.gov