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

NCT04804163 | Completed Early Phase 1

• 1 other identifier: QYFYEC 2020-012-02
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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). 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 manipulation into a control signal. After network transmission, the patient side cart (based in other cities in Shandong Province) 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. Fifty patients with urinary diseases 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. Fifty patients with urinary diseases are planned to enroll in the clinical trial.

Conditions

Renal Cell Carcinoma; Adrenal Tumor; Nonfunctioning Kidney

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.

  after the study is completed, up to 4 months

Secondary Outcomes (4)

• operative time

  after the procedure is completed, all data will be collected within 4 months

• blood loss

  after the procedure is completed, all data will be collected within 4 months

• latency time

  during the whole procedure, all data will be collected within 4 months

• hospital stay

  from admission to discharge for each patients, all data will be collected within 5 months

Study Arms (1)

Upper urinary tract disease group

EXPERIMENTAL

Patients with upper urinary diseases (renal cell carcinoma, nonfunctioning kidney and adrenal tumor) will be treated by telesurgery.

Device: telesurgery by domestic robot

Interventions

telesurgery by domestic robot DEVICE

telesurgery of the upper urinary disease by domestic robot

Upper urinary tract disease group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

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: 18803341 BACKGROUND

• 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: 18295861 BACKGROUND

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

  PMID: 12136861 BACKGROUND

• 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: 11923603 BACKGROUND

• 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: 19222048 BACKGROUND

• 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: 27649314 BACKGROUND

• 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: 27123543 BACKGROUND

• 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: 25840895 BACKGROUND

• 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: 26433570 BACKGROUND

• 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: 27194259 BACKGROUND

• 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: 26293795 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Haitao Niu (the department of Urology)

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 18, 2021
• Study Start: February 27, 2021
• Primary Completion: November 25, 2021
• Study Completion: December 30, 2021
• Last Updated: February 16, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)