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)

NCT06082011 | Unknown DMC FDA Device

• 1 other identifier: ISFMT-SP-004
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Surgeries

Keywords

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; high uterosacral ligament suspension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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.

Study Arms (1)

RWS study for SP Gynecological Surgeries

da Vinci SP Surgical System(SP1098)

Device: da Vinci SP Surgical System

Interventions

da Vinci SP Surgical System DEVICE

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

RWS study for SP Gynecological Surgeries

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Central Study Contacts

Weiwei Feng

CONTACT

13918551061; wfeng7347@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 13, 2023
• Study Start: March 28, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-08

Locations

CN (1)