First In Human Study Evaluating the Safety and Performance of the "LapBox" Containment System for Laparoscopic Tissue Morcellation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Device Related Adverse Events Occurrence
研究概览
简要总结
Study to assess the safety, and performance of the LapBox in patients in terms of duration of deployment, organ insertion into the "LapBox" bag, ease of use, success of containment and performance.
详细描述
The LapBox is intended for use as a laparoscopic instrument port and tissue containment system that creates a working space allowing for visualization during power or manual morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy Ten (10) adult female patients, scheduled for the laparoscopic gynecological procedure, with up to 700gr mass to be removed and with no suspicion of malignancy.
Patients scheduled for elective laparoscopic hysterectomy, myomectomy or removal of an adnexal mass where either manual morcellation or power morcellation is needed for tissue will be enrolled. Each patient will be required to participate in 3 visits:
Visit 1: Screening and Enrollment, as part of the pre-operative visit and confirmation of compliance. Such a visit can be more than 1 day.
Visit 2: Laparoscopic organ removal procedure- morcellation utilizing LapBox containment system.
Visit 3:up appointment up to 7 weeks (7 days) post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients indicated for elective surgery requiring laparoscopic hysterectomy, myomectomy where either manual morcellation or power morcellation is needed for tissue removal at which a morcellator for cutting and extraction of tissue is required.
- •Pre- menopausal woman patient age 18-50 years
- •Mass measured with diameter up to 10 cm to be removed
- •Normal Pap test result within the last 24 months prior to enrollment
- •Normal and /or Non-Clinically Significant as per investigator discretion CBC and Blood chemistry test within at least 6 months prior to surgery.
- •Signed an informed consent
排除标准
- •Emergency cases
- •Abdominal wall thickness is greater than 10 cm according to US measurements.
- •Patient requires procedure involving the ovaries (e.g., Oophorectomy, Salpingo)
- •Patient is defined as a "high risk" patient for developing cancer (per standard assessment, including but not limited to imaging)
- •Suspicion of malignant or pre-malignant tissue according to preoperative assessment including US exam within 30 days prior to surgery
- •Known or suspected gynecologic malignancy within the past five years
- •Pacemaker, internal defibrillator/cardio converter
- •Previous extensive pelvic surgery or any other medical procedure which in the investigator's judgment contraindicates the patient's participation
- •Contraindications to anesthesia or abdominal surgery. ASA score above 3
- •Concurrent participation in any other clinical study
- •Active infection at the time of the procedure.
- •BMI<20 or BMI>40
- •Known history or presence of any medical disorder, which in the investigator's judgment contraindicates the patient's participation (e.g., Known and documented active liver disease, renal failure, cognitive disorder, cardiopulmonary disease, impaired coagulation parameters, etc.)
结局指标
主要结局
Device Related Adverse Events Occurrence
时间窗: through study procedure, up to 10 weeks from procedure
Occurrence of device use related adverse events as documented and reported, under DSMB review
Device Performance and Integrity
时间窗: following completion of procedure and study device use (1 day)
Leak testing will be performed following the each procedure to confirm device integrity. Used device will be filled with color fluid to provide clear identification of possible leakage. Test will performed by Investigator delegated study team member and results will be documented in CRF.
次要结局
- Device performance(up to 10 weeks following the procedure)
- Device Performance (usability)(following completion of procedure and study devise use (1 day))
- Device Performance(following completion of procedure and study devise use (1 day))