Novel Senhance Robotic System in Urologic Surgery: Its Clinical Application and Implication

Surgery Clinical Trial

Official title:

Novel Senhance Robotic System in Urologic Surgery: Its Clinical Application and Implication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982822
• Other study ID #: 202004072RINA
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2022
• Source: National Taiwan University Hospital
• Contact: LunHsiang Yuan, MD
• Phone: 0921254585
• Email: lunhsiang.yuan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational study to collect data from the participants who received urologic surgeries using the Senhance Robotic system.

Description:

This is an observational study and investigators will collect peri-operative demographic data, and short-term outcomes (3-6 months) from the participants who received minimal invasive surgeries using Senhance robotic system in the National Taiwan University Hospital Yunlin Branch, Urology Department. The investigators want to demonstrate if the robotic system is safe and feasible in urologic laparoscopic surgeries.

The operation included TEP, radical prostatectomy, radical nephrectomy (nephroureterectomy) , adrenalectomy, radical cystectomy, and ureter surgery et al.

up to 2022/12, we had recruited 127 TEP, 83 radical prostatectomies, 17 adrenalectomies, 40 nephrectomies, 29 partial nephrectomies, 13 radical cystectomies and 18 other surgeries, such as ureter surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years
• Eligibility: Patients undergo laparoscopic urologic surgeries

Related Conditions & MeSH terms

• Surgery
• Urologic Diseases

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative complications	Using Clavien-Dindo classification to record the safety outcome	postoperative 30 days
Primary	short-term outcome	the short-term outcome was according to a different surgery, such as post-operative 3 months PSA, incontinence rate in radical prostatectomy,	3-6 months