NCT07120945进行中（未招募）不适用
A Prospective, Multicenter, Single-arm Pre-market Study of the Medtronic Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Surgical success rate
研究概览
简要总结
The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.
详细描述
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 22 years) as required by local law
- •Patients indicated for a hysterectomy (radical, modified radical, or total hysterectomy) inclusive of subjects being treated for malignancies with the Hugo™ RAS system
- •Patient is an acceptable candidate for a fully robotic-assisted surgical procedure, a laparoscopic surgical procedure, and an open surgical procedure
- •The patient is willing to participate and consents to participate, as documented by a signed and dated informed consent form
排除标准
- •Patient for whom minimally invasive surgery is contraindicated as determined by the Investigator.
- •Patients with comorbidities or medical characteristics which would preclude the surgical procedure in the opinion of the Investigator.
- •Patients with an estimated life expectancy of less than 6 months as determined by Investigator
- •Patients diagnosed with a bleeding disorder and/or who cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
- •Patients who are pregnant at the time of the surgical procedure.
- •Patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity).
- •Patients who have participated or are currently participating in an investigational drug or in a device research study that may interfere with this study in the opinion of the Investigator.
- •Patients with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia at physicians' discretion.
- •Patients with a pre-surgical diagnosis of recurring cancer and gross metastatic conditions are excluded.
- •I. For cervical cancer, only patients with Stages 1a1, 1a2, 1b1, may be included, and within these stages, II. Eligibility is further restricted to those with Stage IB1 tumors less than 2 cm (on MRI) and less than 10 mm stromal invasion on excisional biopsy, or less than 50% cervical stromal invasion (on MRI).
- •III. All other cervical cancer stages are excluded from the study.
- •Patients with disease spread out of the pelvis requiring surgical intervention with surgical expertise outside of the gynecological space, with the exception of para-aortic lymph node dissection, as determined by the investigator.
- •Patients who have a body mass index (BMI) > 44.1 kg/m2
研究组 & 干预措施
Robotic-Assisted Surgery (RAS) Hysterectomy Procedures
Experimental
Patients indicated for Robotic-Assisted Surgery (RAS) for hysterectomy procedures (radical, modified radical, or total hysterectomy), inclusive of subjects being treated for malignancies.
干预措施: Robotic Assisted-Surgery (RAS) Hysterectomy (Device)
结局指标
主要结局
Surgical success rate
时间窗: Intraoperative
Surgical success rate is the procedure utilizing Hugo™ as outlined in the preoperatively defined surgical plan without conversion to an alternative robotic-assisted system, laparoscopy, or open surgery.
次要结局
- Operative time(Intraoperative)
- Hospital length of stay(From procedure to discharge, through approximately 30 days)
- Major complication rate(30 Days)
- Complication rate(30 Days)
- Rate of intraoperative adverse events(Intraoperative)
- Rate of readmission(30 Days)
- Rate of therapy-specific adverse events(3 Months)
研究者
研究点 (7)
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