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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecological Surgeries
• Intervention / Treatment: Device: da Vinci SP Surgical System

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Weiwei Feng; Phone Number: 13918551061; Email: wfeng7347@aliyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital
      • Contact: Tianjiao Lyu, PhD; Phone Number: 008613482445868; Email: ltj12196@rjh.com.cn
      • Contact: Yahui Jiang, PhD; Phone Number: 008613918551061; Email: fww12066@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have received or plan to receive single-port 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: vaginal hysterectomy; ovarian cystectomy; myomectomy; total hysterectomy; radical hysterectomy; salpingectomy/oophorectomy; deep endometriosis resection; pelvic and abdominal lymphadenectomy; sentinel lymph node resection by image development; uterus/vagino-sacral colpopexy; high uterosacral ligament suspension
• Other Study ID Numbers: ISFMT-SP-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes