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)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Gynecological Surgeries

Treatments: Device: da Vinci SP Surgical System

Study type: Observational

Funder types: Other

Identifiers

NCT06082011

ISFMT-SP-004

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

RWS study for SP Gynecological Surgeries

Description:

da Vinci SP Surgical System(SP1098)

Treatment:

Device: da Vinci SP Surgical System