Clinical trial · Interventional
Research on the Effectiveness and Safety of Remote Control of Domestic Surgical Robot System for Urinary Surgery
Research on the Effectiveness and Safety of Remote Surgery of Domestic Surgical Robot System for Urinary System Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Tumor | Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Nonfunctioning Kidney | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| telesurgery by domestic robot | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Upper urinary tract disease group
- description
- Patients with upper urinary diseases (renal cell carcinoma, nonfunctioning kidney and adrenal tumor) will be treated by telesurgery.
- interventionNames
- Device: telesurgery by domestic robot
Primary outcomes (1)
- measure
- success rate of the telesurgery
- timeFrame
- after the study is completed, up to 4 months
- description
- 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.
Secondary outcomes (4)
- measure
- operative time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (11)
- BACKGROUNDNguan 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
- BACKGROUNDSterbis 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
- BACKGROUNDClayman RV. Transatlantic robot-assisted telesurgery. J Urol. 2002 Aug;168(2):873-4. No abstract available. PMID 12136861
- BACKGROUNDMarescaux 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
- BACKGROUNDGarcia 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
- BACKGROUNDLefranc 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
- BACKGROUNDAbdel 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