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RecruitingNCT06987552Updated May 23, 2025

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

An interventional study of Da Vinci SP Surgical System in Upper Tract Urothelial Cancer, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Upper Tract Urothelial Cancer
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    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

    Device: Da Vinci SP Surgical System

Interventions

  • DeviceDa Vinci SP Surgical System

    Da Vinci SP Surgical System

06

What researchers measure

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.

    Time frame: During Surgery

Secondary outcomes

  1. Perioperative Parameters: Operative Time

    First skin incision to closure of wound by minutes.

    Time frame: immediately after the surgery

  2. Perioperative Parameters: Console Time

    Surgeon on Console Time by minutes

    Time frame: immediately after the surgery

  3. Perioperative Parameters: Transfusion

    Blood transfusion amount by bags

    Time frame: immediately after the surgery

  4. Perioperative Parameters: Estimated Blood Loss

    Estimated blood loss by mL

    Time frame: immediately after the surgery

  5. Postoperative Parameters: Length of Stay

    Total length of stay = discharge date - admission date

    Time frame: 30 days post operation

  6. Complication

    Intraoperative and/or postoperative complication rate in 30 days by Clavien-Dindo Classification

    Time frame: 30 days post operation

  7. Postoperative Parameters: Readmission

    Readmission rate by %

    Time frame: 30 days post operation

  8. Postoperative Parameters: Reoperation

    Reoperation rate by %

    Time frame: 30 days post operation

  9. Perioperative Mortality

    Mortality by %

    Time frame: 30 days post operation

  10. Pain Score

    measured by Visual Analogue Scale (VAS) for pain assessment at baseline, post operation, and discharge day. VAS ranged from 0 to 10, representing no pain to extreme pain.

    Time frame: 30 days post operation

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    • SHIH-CHIEH CHUEH · Contact
    Recruiting
08

References and documents

Study documents

  • Study protocol · Oct 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06987552
Lead sponsor
National Taiwan University Hospital
Collaborators
Intuitive Surgical
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Dec 24, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
May 23, 2025

Study contacts

SHIH-CHIEH CHUEH, DIRECTOR
Contact
jeffchueh@gmail.com
02 23123456 ext. 262134
Taiwan National Taiwan University Hospital, DIRECTOR
Contact
jeffchueh@gmail.com
02 23123456 ext. 262134
Shih-Chieh Chueh
study director · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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