Clinical trial NCT06181942: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
Official title: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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) 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.


Eligibility criteria: Inclusion Criteria:

Subjects should meet all the following criteria:

1. 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;
2. 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).

Exclusion Criteria:

The subjects meeting any of the following criteria should be excluded.

1. Patients with missing data on the primary endpoint in retrospective cases;
2. Subjects having any contraindications of single-port robot surgery;
3. The intraoperative anatomy determined that minimally invasive surgery was not suitable;
4. Patients who are considered inappropriate to participate in this Study by investigators.

Primary outcomes:
measure: Intraoperative conversion rate
timeFrame: Intraoperative
measure: incidence of device-related or likely related complications
timeFrame: 30 days
Secondary outcomes:
measure: Intraoperative bleeding volume
timeFrame: Intraoperative
measure: The rate of intraoperative blood transfusion
timeFrame: Intraoperative
measure: Surgical duration
timeFrame: Intraoperative
measure: Length of stay (LOS)
timeFrame: up to 4 weeks
measure: Admission to ICU and ICU LOS
timeFrame: up to 4 weeks
measure: Urethral catheter indwelling duration
timeFrame: up to 4 weeks
measure: Postoperative pain score
timeFrame: follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery.
measure: Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function
timeFrame: in the follow-up 1 month after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: