NCT06987552

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 24, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 23, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

February 25, 2025

Last Update Submit

May 15, 2025

Conditions

Upper Tract Urothelial Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of conversion rate

    The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.

    During Surgery

Secondary Outcomes (10)

  • Perioperative Parameters: Operative Time

    immediately after the surgery

  • Perioperative Parameters: Console Time

    immediately after the surgery

  • Perioperative Parameters: Transfusion

    immediately after the surgery

  • Perioperative Parameters: Estimated Blood Loss

    immediately after the surgery

  • Postoperative Parameters: Length of Stay

    30 days post operation

  • +5 more secondary outcomes

Study Arms (1)

Operation of focus procedure with da Vinci SP Surgery System

EXPERIMENTAL

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

Device: Da Vinci SP Surgical System

Interventions

Da Vinci SP Surgical SystemDEVICE

Da Vinci SP Surgical System

Operation of focus procedure with da Vinci SP Surgery System

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Shih-Chieh Chueh

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

SHIH-CHIEH CHUEH, DIRECTOR

CONTACT

02 23123456jeffchueh@gmail.com

Taiwan National Taiwan University Hospital, DIRECTOR

CONTACT

02 23123456jeffchueh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

May 23, 2025

Study Start

December 24, 2024

Primary Completion

June 30, 2025

Study Completion

January 1, 2026

Last Updated

May 23, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)