Urological SurgeriesSPiM-RWS-URONCT06181942
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
An observational study of Urological Surgeries, run by Ruijin Hospital at 1 site in China.
Trial summary
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries； Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urological Surgeries
- What is being tested?
- SP
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects who have received or plan to receive radical prostatectomy (RP), partial nephrectomy (PN), radical nephrectomy (RN), radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries with the SP single-port robot.
Who may be able to join
- Subjects should meet all the following criteria:
- Subjects who have received or plan to receive RP, PN, RN, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic surgeries with the SP single-port robot;
- Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Who cannot join
- The subjects meeting any of the following criteria should be excluded.
- Patients with missing data on the primary endpoint in retrospective cases;
- Subjects having any contraindications of single-port robot surgery;
- The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- Patients who are considered inappropriate to participate in this Study by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Danfeng Xu, （021）64370045 ext. 666062, xdf12036@rjh.com.cn
Danfeng Xu
About this study
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries；
Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
Study design：Retrospective + prospective, real-world study
Investigational medical device： English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
- Conditions
- Urological Surgeries
- Being tested
- SP
- Keywords
- SP single-port robot, radical prostatectomy, partial nephrectomy, radical nephrectomy, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPDevice
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
| Study group | Role | What they receive |
|---|---|---|
| single-port urological surgeries with the SP single-port robot | who have received or plan to receive radical prostatectomy (RP), partial nephrectomy (PN), radical nephrectomy (RN), radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries with the SP single-port robot. Receives: Device: SP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative conversion rate
Measured: Intraoperative
incidence of device-related or likely related complications
Measured: 30 days
Secondary outcomes (8)
Intraoperative bleeding volume
Measured: Intraoperative
The rate of intraoperative blood transfusion
Measured: Intraoperative
Surgical duration
Measured: Intraoperative
Length of stay (LOS)
Measured: up to 4 weeks
Admission to ICU and ICU LOS
Measured: up to 4 weeks
Urethral catheter indwelling duration
Measured: up to 4 weeks
Postoperative pain score
Measured: follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery.
Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function
Measured: in the follow-up 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start22 Feb 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological SurgeriesStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danfeng Xu, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181942
- Sponsor's protocol ID
- ISFMT-SP-001
- Acronym
- SPiM-RWS-URO
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
- ClinicalTrials.gov ID
- NCT06181942
- Acronym / sponsor ID
- SPiM-RWS-URO / ISFMT-SP-001
- Conditions
- Urological Surgeries
- Keywords
- SP single-port robot, radical prostatectomy, partial nephrectomy, radical nephrectomy, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries；
Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
Study design：Retrospective + prospective, real-world study
Investigational medical device： English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-port urological surgeries with the SP single-port robot | – | Device: SPwho have received or plan to receive radical prostatectomy (RP), partial nephrectomy (PN), radical nephrectomy (RN), radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries with the SP single-port robot. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who have received or plan to receive radical prostatectomy (RP), partial nephrectomy (PN), radical nephrectomy (RN), radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological surgeries with the SP single-port robot.
Key inclusion criteria (3 listed)
- Subjects who have received or plan to receive RP, PN, RN, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic surgeries with the SP single-port robot;
- Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Key exclusion criteria (5 listed)
- The subjects meeting any of the following criteria should be excluded.
- Patients with missing data on the primary endpoint in retrospective cases;
- Subjects having any contraindications of single-port robot surgery;
- The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- Patients who are considered inappropriate to participate in this Study by investigators.
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 |
|---|---|---|
| SPEnglish name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc. | Device | single-port urological surgeries with the SP single-port robot |
Primary outcome
Intraoperative conversion rate
Time frame: Intraoperative
incidence of device-related or likely related complications
Time frame: 30 days
8 secondary outcomes
Intraoperative bleeding volume
Time frame: Intraoperative
The rate of intraoperative blood transfusion
Time frame: Intraoperative
Surgical duration
Time frame: Intraoperative
Length of stay (LOS)
Time frame: up to 4 weeks
Admission to ICU and ICU LOS
Time frame: up to 4 weeks
Urethral catheter indwelling duration
Time frame: up to 4 weeks
Postoperative pain score
Time frame: follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery.
Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function
Time frame: in the follow-up 1 month after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urological Surgeries, run by Ruijin Hospital at 1 site in China.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative conversion rate (time frame: Intraoperative). The study lists 2 primary outcomes in all. 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 26 Dec 2023.