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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RWS study for SP Gynecological Surgeries | da Vinci SP Surgical System(SP1098) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci SP Surgical System | Device | Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding volume | Intraoperative | |
| Intraoperative blood transfusion rate | Intraoperative | |
| Surgical duration |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiwei Feng | Contact | 13918551061 | wfeng7347@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai JiaoTong University School of Medicine affliated Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| 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. |
| Postoperative pain score | during the follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery |