Upper Tract Urothelial CancerNCT06987552
Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
A study testing Da Vinci SP Surgical System in people with Upper Tract Urothelial Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Upper Tract Urothelial Cancer
- What is being tested?
- Da Vinci SP Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan National Taiwan University Hospital, DIRECTOR contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
SHIH-CHIEH CHUEH
About this study
Official title: A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
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
- Conditions
- Upper Tract Urothelial Cancer
- Being tested
- Da Vinci SP Surgical System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci SP Surgical SystemDevice
Da Vinci SP Surgical System
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Da Vinci SP Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Surgery
Secondary outcomes (10)
Perioperative Parameters: Operative Time
First skin incision to closure of wound by minutes.
Measured: immediately after the surgery
Perioperative Parameters: Console Time
Surgeon on Console Time by minutes
Measured: immediately after the surgery
Perioperative Parameters: Transfusion
Blood transfusion amount by bags
Measured: immediately after the surgery
Perioperative Parameters: Estimated Blood Loss
Estimated blood loss by mL
Measured: immediately after the surgery
Postoperative Parameters: Length of Stay
Total length of stay = discharge date - admission date
Measured: 30 days post operation
Complication
Intraoperative and/or postoperative complication rate in 30 days by Clavien-Dindo Classification
Measured: 30 days post operation
Postoperative Parameters: Readmission
Readmission rate by %
Measured: 30 days post operation
Postoperative Parameters: Reoperation
Reoperation rate by %
Measured: 30 days post operation
Perioperative Mortality
Mortality by %
Measured: 30 days post operation
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.
Measured: 30 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start24 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urothelial CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Sponsor
- Investigators
- Shih-Chieh Chueh, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987552
- Sponsor's protocol ID
- 202409016DIPD
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
- ClinicalTrials.gov ID
- NCT06987552
- Acronym / sponsor ID
- 202409016DIPD
- Conditions
- Upper Tract Urothelial Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Intuitive Surgical
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
Detailed description
To evaluate safety, surgical outcomes, patient characteristics, and patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operation of focus procedure with da Vinci SP Surgery System | Experimental | Device: Da Vinci SP Surgical SystemSingle-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients with Upper Tract Urothelial Cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Da Vinci SP Surgical SystemDa Vinci SP Surgical System | Device | Operation of focus procedure with da Vinci SP Surgery System |
Primary outcome
Incidence of conversion rate
Time frame: During Surgery
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.
10 secondary outcomes
Perioperative Parameters: Operative Time
Time frame: immediately after the surgery
Perioperative Parameters: Console Time
Time frame: immediately after the surgery
Perioperative Parameters: Transfusion
Time frame: immediately after the surgery
Perioperative Parameters: Estimated Blood Loss
Time frame: immediately after the surgery
Postoperative Parameters: Length of Stay
Time frame: 30 days post operation
Complication
Time frame: 30 days post operation
Postoperative Parameters: Readmission
Time frame: 30 days post operation
Postoperative Parameters: Reoperation
Time frame: 30 days post operation
Perioperative Mortality
Time frame: 30 days post operation
Pain Score
Time frame: 30 days post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taiwan National Taiwan University Hospital, DIRECTOR contact
Shih-Chieh Chueh study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Da Vinci SP Surgical System in people with Upper Tract Urothelial Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SHIH-CHIEH CHUEH, DIRECTOR (02 23123456 ext. 262134, jeffchueh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of conversion rate (time frame: During Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.