Идёт набор NCT06201429

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.

Без фазы С лечением Clinical Need for Craniotomy or Craniectomy Clinical Need for Cranioplasty

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mechanical Tissue Resuscitation™ (MTR®).
Кому может быть актуально: Состояния в реестре: Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty. Базовые параметры: 22 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

Вмешательства

Устройство Mechanical Tissue Resuscitation™ (MTR®)
Mechanical Tissue Resuscitation™ (MTR®) to drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/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).

Первичные конечные точки

Safety and effectiveness of MTR® [Срок оценки: 30 days]

Вторичные конечные точки (6)

MTR® Success [Срок оценки: 30 days]
AEs/SAEs Frequency [Срок оценки: 30 days]
Ability to remove fluid [Срок оценки: 7 days]
Operator ease survey [Срок оценки: 1 day (during day of surgery)]
Health care professional (HCP) ease survey [Срок оценки: 1 day (during day of surgery)]
Data Integrity [Срок оценки: 30 days]

Критерии участия

Критерии включения

Phase 1:

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'.

Phase 2:

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.

Phase 3:

All Phase 1 criteria
Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.

Критерии исключения

Phase 1:

Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
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) > 1.5.
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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет