NCT04982822

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

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

December 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

July 23, 2021

Last Update Submit

June 24, 2024

Conditions

Urologic DiseasesSurgery

Keywords

UrologySenhanceRobotic surgical systemLaparoscopic surgery

Outcome Measures

Primary Outcomes (2)

  • Peri-operative complications

    Using Clavien-Dindo classification to record the safety outcome

    postoperative 30 days

  • 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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study populations consisted of aged from 18 years old to 90 years old and had will to receive laparoscopic surgeries using the Senhance robotic system. The were excluded if there's major severe cardio-pulmonary condition or had received extensive abdominal surgeries.

Patients undergo laparoscopic urologic surgeries

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Outside U.S./Canada, Taiwan

Location

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • LunHsiang Yuan, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2021

First Posted

July 29, 2021

Study Start

December 1, 2020

Primary Completion

December 31, 2022

Study Completion

January 31, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations

TW(1)