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)

Recruiting

• Conditions: Gynecological Surgeries
• Interventions: Device: da Vinci SP Surgical System

• Registration Number: NCT06082011
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Status Verified: 2023-08
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-10-08
• Last Update Submitted: 2023-10-08
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. 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.
2. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RWS study for SP Gynecological Surgeries	da Vinci SP Surgical System	da Vinci SP Surgical System(SP1098)

Primary Outcome Measures

Name	Time	Method
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
Primary efficacy endpoint: Intraoperative conversion rate	Intraoperative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China