Evaluating the da Vinci SP Surgical System for Gynecological Surgeries
Official title: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries
Run by Ruijin Hospital · NCT06082011 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
|---|---|
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06082011 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include female patients planning to undergo specific gynecological surgeries with the da Vinci SP Surgical System.
✕Probably not a fit
Patients who have contraindications for single-port robotic surgery or those deemed inappropriate for the study by investigators may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with robotic surgical systems, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital
Shanghai, Shanghai, China Recruiting
Study contacts
- Study coordinator: Weiwei Feng
- Email: wfeng7347@aliyun.com
- Phone: 13918551061
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.