A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06082011

Collaborator

(none)

Enrollment

Location

21.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological 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 robotic surgeries of gynecological benign and malignant tumors 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

English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer:

Intuitive Surgical, Inc.

Condition or Disease	Intervention/Treatment	Phase
Gynecological Surgeries	Device: da Vinci SP Surgical System

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries

Actual Study Start Date :

Mar 28, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
RWS study for SP Gynecological Surgeries da Vinci SP Surgical System(SP1098)	Device: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Arm

Intervention/Treatment

RWS study for SP Gynecological Surgeries

da Vinci SP Surgical System(SP1098)

Device: da Vinci SP Surgical System

Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.

Outcome Measures

Primary Outcome Measures

Primary efficacy endpoint: Intraoperative conversion rate [Intraoperative]
Primary safety endpoint: Incidence of device related or possibly related complications meeting the Clavien-Dindo Grading System level 3 or above criteria within 30 days after the surgery [30 days]

Secondary Outcome Measures

Intraoperative bleeding volume [Intraoperative]
Intraoperative blood transfusion rate [Intraoperative]
Surgical duration [Intraoperative]
Length of stay (LOS) [During the follow-up 1 day before discharge.The LOS is defined as the total inpatient days of each subject from the day of the surgery to the day of discharge (unit: days).]
Admission to ICU and ICU LOS [During the follow-up 1 day before discharge, the admission to ICU and ICU LOS (unit: days) of each subject should be recorded.]
Postoperative pain score [during the follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Female patients who have received or plan to receive gynecological surgeries with the SP single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension.
Patients who voluntarily participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).

Exclusion Criteria:

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