Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients

NCT ID: NCT06987552

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-24

Study Completion Date

2026-01-01

Brief Summary

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To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery

Detailed Description

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To evaluate safety, surgical outcomes, patient characteristics, and patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery

Conditions

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Upper Tract Urothelial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operation of focus procedure with da Vinci SP Surgery System

Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients with Upper Tract Urothelial Cancer

Group Type EXPERIMENTAL

Da Vinci SP Surgical System

Intervention Type DEVICE

Da Vinci SP Surgical System

Interventions

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Da Vinci SP Surgical System

Da Vinci SP Surgical System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 20 years or more
* Histologically or cytologically diagnosed upper tract urothelial cancer
* Fitting indications of radical nephroureterectomy and ipsilateral bladder cuff resection, and deemed feasible for robotic surgery
* ASA physical status classification 1-2 and adequate organ function
* Patients willing and able to comply with study protocol requirements and follow-up
* With informed consent

Exclusion Criteria

* Synchronous bladder cancer
* Distant metastasis of cancer
* BMI ≥30 or BMI \<18.5
* Unable to tolerate lateral decubitus or Trendelenburg position (relative contra-indication)
* Severe adhesion due to prior abdominopelvic surgery (relative contra-indication)
* Previous radiation treatment to the pelvic area
* Active infectious disease
* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions, such as: severe heart disease (NYHA functional class III-IV) or severe lung disease (GOLD Group C-D)
* Cannot follow trial-required procedures
* Concomitant systemic or pelvic disease that increases the risk of surgery
* Long-term use of anti-coagulant(s)
* Patients with coagulopathy
* Emergency surgery
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shih-Chieh Chueh

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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SHIH-CHIEH CHUEH, DIRECTOR

Role: CONTACT

02 23123456 ext. 262134

Taiwan National Taiwan University Hospital, DIRECTOR

Role: CONTACT

02 23123456 ext. 262134

Facility Contacts

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SHIH-CHIEH CHUEH

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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202409016DIPD

Identifier Type: -

Identifier Source: org_study_id

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