Evaluating the da Vinci SP Surgical System for Gynecological Surgeries

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

This study is testing a new robotic surgery tool to see if it is safe and effective for women having gynecological surgeries like hysterectomies and myomectomies.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06082011 on ClinicalTrials.gov

What this trial studies

This study aims to assess the clinical performance and safety of the da Vinci SP Surgical System, a robotic surgical tool, specifically for single-port gynecological surgeries. It will gather real-world evidence from both retrospective and prospective data involving female patients undergoing various gynecological procedures, such as hysterectomies and myomectomies. The goal is to provide insights into the effectiveness and safety of this technology in treating benign and malignant tumors within the Chinese population.

Who should consider this trial

Good fit: Ideal candidates include female patients planning to undergo specific gynecological surgeries with the da Vinci SP Surgical System.

Not a fit: Patients who have contraindications for single-port robotic surgery or those deemed inappropriate for the study by investigators may not benefit.

Why it matters

Potential benefit: If successful, this study could enhance surgical outcomes and safety for women undergoing gynecological surgeries using robotic assistance.

How similar studies have performed: Other studies have shown promising results with robotic surgical systems, indicating potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Weiwei Feng

Conditions: Gynecological Surgeries, radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection