NCT04570176

Brief Summary

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 are planned to enroll in the clinical trial. Main judgment criterion: The robot-assisted telesurgery did not transfer to other types of surgery, such as open surgery or normal robot-assisted surgery. Secondary judgment criterion: operative time, blood loss, postoperative pain, preoperative adjusting time and hospitalization time. Patient enrollment: This trial aims to explore the safety and effectiveness of the domestically produced robotic system in remote clinical diagnosis and treatment through 5G network. Six patients are planned to enroll in the clinical trial, including 2 patients with adrenal tumor, 2 patients with bladder cancer and 2 patients with renal cell carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

February 16, 2022

Status Verified

September 1, 2020

Enrollment Period

26 days

First QC Date

September 22, 2020

Last Update Submit

February 15, 2022

Conditions

Renal Cell CarcinomaBladder CancerAdrenal Tumor

Outcome Measures

Primary Outcomes (1)

  • success rate of the telesurgery

    The success of the telesurgery is the robot-assisted telesurgery did not transfer to other types of surgery， such as open surgery or normal robot-assisted surgery. The number of the success divided by the total number is the success rate.

    during the procedure

Secondary Outcomes (3)

  • operative time

    during the procedure

  • blood loss

    during the procedure

  • latency time

    during the procedure

Study Arms (1)

Urologic tumor group

EXPERIMENTAL

patients with adrenal adenoma, muscle-invasive bladder cancer or renal cell carcinoma are included in the experiment.

Procedure: adrenalectomy for adrenal adenoma

Interventions

adrenalectomy for adrenal adenomaPROCEDURE

adrenalectomy， cystectomy and nephrectomy

Also known as: cystectomy for muscle-invasive bladder cancer, nephrectomy for patients with renal cell carcinoma.
Urologic tumor group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-III
  • BMI: 18-30Kg/m2
  • adrenal tumors that need adrenalectomy (hormonally active or grow more than 1cm during annual evaluation； other benign adrenal tumors)
  • patients with Robson Stage I or II renal cell carcinoma that need radical nephrectomy
  • patients with Clinical Stage I or II bladder cancer that need radical cystectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Related Publications (11)

  • Nguan C, Miller B, Patel R, Luke PP, Schlachta CM. Pre-clinical remote telesurgery trial of a da Vinci telesurgery prototype. Int J Med Robot. 2008 Dec;4(4):304-9. doi: 10.1002/rcs.210.

    PMID: 18803341RESULT

  • Sterbis JR, Hanly EJ, Herman BC, Marohn MR, Broderick TJ, Shih SP, Harnett B, Doarn C, Schenkman NS. Transcontinental telesurgical nephrectomy using the da Vinci robot in a porcine model. Urology. 2008 May;71(5):971-3. doi: 10.1016/j.urology.2007.11.027. Epub 2008 Mar 4.

    PMID: 18295861RESULT

  • Clayman RV. Transatlantic robot-assisted telesurgery. J Urol. 2002 Aug;168(2):873-4. No abstract available.

    PMID: 12136861RESULT

  • Marescaux J, Leroy J, Rubino F, Smith M, Vix M, Simone M, Mutter D. Transcontinental robot-assisted remote telesurgery: feasibility and potential applications. Ann Surg. 2002 Apr;235(4):487-92. doi: 10.1097/00000658-200204000-00005.

    PMID: 11923603RESULT

  • Garcia P, Rosen J, Kapoor C, Noakes M, Elbert G, Treat M, Ganous T, Hanson M, Manak J, Hasser C, Rohler D, Satava R. Trauma Pod: a semi-automated telerobotic surgical system. Int J Med Robot. 2009 Jun;5(2):136-46. doi: 10.1002/rcs.238.

    PMID: 19222048RESULT

  • Lefranc M, Peltier J. Evaluation of the ROSA Spine robot for minimally invasive surgical procedures. Expert Rev Med Devices. 2016 Oct;13(10):899-906. doi: 10.1080/17434440.2016.1236680. Epub 2016 Sep 30.

    PMID: 27649314RESULT

  • Abdel Raheem A, Troya IS, Kim DK, Kim SH, Won PD, Joon PS, Hyun GS, Rha KH. Robot-assisted Fallopian tube transection and anastomosis using the new REVO-I robotic surgical system: feasibility in a chronic porcine model. BJU Int. 2016 Oct;118(4):604-9. doi: 10.1111/bju.13517. Epub 2016 May 26.

    PMID: 27123543RESULT

  • Fanfani F, Monterossi G, Fagotti A, Rossitto C, Gueli Alletti S, Costantini B, Gallotta V, Selvaggi L, Restaino S, Scambia G. The new robotic TELELAP ALF-X in gynecological surgery: single-center experience. Surg Endosc. 2016 Jan;30(1):215-21. doi: 10.1007/s00464-015-4187-9. Epub 2015 Apr 4.

    PMID: 25840895RESULT

  • Moglia A, Ferrari V, Morelli L, Ferrari M, Mosca F, Cuschieri A. A Systematic Review of Virtual Reality Simulators for Robot-assisted Surgery. Eur Urol. 2016 Jun;69(6):1065-80. doi: 10.1016/j.eururo.2015.09.021. Epub 2015 Oct 1.

    PMID: 26433570RESULT

  • Yi B, Wang G, Li J, Jiang J, Son Z, Su H, Zhu S, Wang S. Domestically produced Chinese minimally invasive surgical robot system "Micro Hand S" is applied to clinical surgery preliminarily in China. Surg Endosc. 2017 Jan;31(1):487-493. doi: 10.1007/s00464-016-4945-3. Epub 2016 May 18.

    PMID: 27194259RESULT

  • Yi B, Wang G, Li J, Jiang J, Son Z, Su H, Zhu S. The first clinical use of domestically produced Chinese minimally invasive surgical robot system "Micro Hand S". Surg Endosc. 2016 Jun;30(6):2649-55. doi: 10.1007/s00464-015-4506-1. Epub 2015 Aug 21.

    PMID: 26293795RESULT

MeSH Terms

Conditions

Carcinoma, Renal CellUrinary Bladder NeoplasmsAdrenal Gland Neoplasms

Interventions

AdrenalectomyCystectomyNephrectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesEndocrine Gland NeoplasmsAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Haitao Niu, PhD

    The Affiliated Hospital of Qingdao University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Haitao Niu

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 30, 2020

Study Start

August 27, 2020

Primary Completion

September 22, 2020

Study Completion

November 30, 2021

Last Updated

February 16, 2022

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)