HYbrid RObotic Surgery in Gynecology (HYROS-GYN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Lack of occurrence of a SAE related to the use of the medical devices under investigation during the intervention.
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety and performance of ROB and its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in patients with the indication of robot assisted laparoscopic Hysterectomy, Hysterectomy and Salpingectomy or Hysterectomy and Salpingectomy and Oophorectomy and when it applies Lysis of Adhesions, Lymphadenectomy and Sentinel lymph node biopsy (SLNB).
HYROS-GYN is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by ROB which operates exclusively under surgeon's orders. It will include the data collected up to 30 days post-surgery.
详细描述
The ROB-Bitrack System is 4-arms on demand open and portable robotic platform indicated to be used during general abdominal laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for endoscopic visualization and manipulation of tissue. The HYROS-GYN clinical investigation will evaluate the safety and performance of ROB and its corresponding ESE and NESE Endoscopic instruments and accessories. It will include 9 patients and will be conducted in two sites, with a single arm, open-label, and non-randomized design,. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 7-Days, 14-Days and 30-Days Follow-up visits . The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy.The expected duration of the study is 6 months from the first patient enrolled to the last visit of the last patient follow up.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Subjects with a gynecological indication for a laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy (i.e., removal of one or both fallopian tubes and/or ovaries).
- •- Subjects that additionally to the hysterectomy procedure may require sentinel lymph node biopsy (SLN) and/or pelvic lymphadenectomy (LND) according to investigator criteria.
- •- Ability and willingness to comply with all study requirements to be evaluated for each study visit
排除标准
- •- Pregnant or breastfeeding women at the time of the surgery
- •- Subjects with a medical indication for radical hysterectomy (e.g., suspected or confirmed invasive cervical cancer or other conditions requiring radical surgical management).
- •- Subjects who had been treated with radiation therapy previous to the surgery.
- •- Subjects with uterine enlargement >8 cm for which morcellation would not allow for vaginal removal.
- •- Subjects with a BMI ≥ 40
- •- Subjects not suitable to undergo MIS/MIRS, according to medical criteria:
- •with severe concomitant illness (e.g., severe cardiopulmonary, corornary artery disease or bleeding disorders)
- •that have been submitted to multiple previous abdominal surgeries with multiple adhesions . 7- Subjects admitted to the hospital due to an emergency situation.
- •8 - Subjects with untreated active infection 9 - Subject with any contraindication for the use of Bitrack Sytem & ESE/NESE Instruments and/or known allergy to some of the device components (i.e., stainless steel, etc.) 10 - Subjects with life expectancy inferior to 3 months 11 - Subjects with abuses of active substances or with uncontrolled psychiatric disorders 12 - Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system. 13 - Inability to adhere to study-related procedures 14 - Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements
研究组 & 干预措施
Patients surgically treated with ROB Bitrack System and ESE/ NESE instruments and accessories
干预措施: Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy (Procedure)
结局指标
主要结局
Lack of occurrence of a SAE related to the use of the medical devices under investigation during the intervention.
时间窗: During the procedure
Evaluation of ROB Bitrack System to assist in the accurate control of its compatible ESE/NESE instruments, establishing as hypothesis that they perform as intended by the surgeon (performance score scale ≥ 3) during the intervention without causing any particular SAE related to the use of the medical devices under investigation, when devices are all used according to the respective instructions for use.
Performance
时间窗: During the pocedure
Assessment with a "Surgeon performance scale" to confirm that the ROB Bitrack System and ESE/NESE instruments perform as intended during the surgery.
次要结局
未报告次要终点