Status:
UNKNOWN
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)
Lead Sponsor:
Ruijin Hospital
Conditions:
Gynecological Surgeries
Eligibility:
All Genders
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 s...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
March 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06082011
Start Date
March 28 2023
End Date
December 31 2024
Last Update
October 13 2023
Active Locations (1)
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1
Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200011