A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Safety and effectiveness of MTR™
研究概览
简要总结
A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and require drainage for fluid removal.
详细描述
Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid.
This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy.
The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).
The study will be conducted in subsequent phases, to enroll patients in the following populations:
- Phase 1: patients undergoing elective procedures;
- Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and
- Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing and able to provide written informed consent or has an appointed legally authorized representative (LAR) who can provide consent on the patient's behalf.
- •The patient's age is ≥ 22 and ≤ 65 years.
- •The patient has a clinical need for a craniotomy, craniectomy, or cranioplasty and for which, as an integral part of their care, a Jackson Pratt (JP) drain or equivalent would be placed at the surgical site.
- •The surgical case is classified as 'clean'.
- •All Phase 1 criteria
- •Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.
- •All Phase 1 criteria
- •Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.
排除标准
- •Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than
- •Patient is pregnant or lactating.
- •Patient's BMI > 45
- •Patient is participating in another clinical investigation.
- •Patient's anticipated survival is < 48 hours.
- •Patient is incarcerated at time of hospital admission.
- •Patient has a coincidental infection.
- •Patient has thrombocytopenia (platelet count < 150,000/µL).
- •Patient has an International Normalized Ratio (INR) > 1.
- •Patient is a known active opioid abuser at the time of surgery.
- •Patient is a known active alcohol abuser at the time of surgery.
- •Active bleeding at the site of surgery prior to placement of the device.
- •Phases 2 and 3:
- •1. Exclusion criteria 2-12 from Phase 1
研究组 & 干预措施
Mechanical Tissue Resuscitation™ (MTR®)
干预措施: Mechanical Tissue Resuscitation™ (MTR®) (Device)
结局指标
主要结局
Safety and effectiveness of MTR™
时间窗: 30 days
The primary endpoint is to evaluate MTR™ as safe and effective for the removal of fluids in those patients who have undergone a craniotomy/craniectomy, and to assess the frequency of device and procedure related adverse events.
Safety and effectiveness of MTR®
时间窗: 30 days
The primary endpoint is to evaluate that MTR® is safe for the removal of fluids in those patients who have undergone a craniotomy/craniectomy/cranioplasty. This endpoint will be assessed by the frequency of device and procedure related adverse events.
次要结局
- MTR™ Success(30 days)
- Data Integrity(30 days)
- Ability to remove fluid(7 days)
- Operator ease survey(1 day (during day of surgery))
- AEs/SAEs Frequency(30 days)
- Health care professional (HCP) ease survey(1 day (during day of surgery))
- MTR® Success(30 days)