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Идёт набор NCT06406790

CraniSeal Post Approval Study

Фаза IV С лечением Leak, Cerebrospinal Fluid

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: CraniSeal, DuraSeal.
Кому может быть актуально
Состояния в реестре: Leak, Cerebrospinal Fluid. Базовые параметры: от 18 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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Официальное название

A Multicenter, Single-Blind, Prospective Randomized Post-Approval Study Comparing the Safety and Effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant for Dural Sealing in Elective Cranial Surgery

Обзор

To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

Вмешательства

  • Устройство CraniSeal
    CraniSeal is a PEG Dural Sealant
  • Устройство DuraSeal
    DuraSeal is a PEG Dural Sealant

Первичные конечные точки

  • Absence of CSF Leaks [Срок оценки: 90 days]

Критерии участия

General Inclusion Criteria:

  • Patient is ≥ 18 years of age
  • Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision
  • Patient requires a procedure involving surgical wound classification Class I/Clean
  • Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures.
  • Patients who are able to comply with study requirements.

General Exclusion Criteria:

  • Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded
  • Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
  • Patient with diagnosis of severely altered renal (creatinine levels > 2.0 mg/dL) or hepatic (total bilirubin > 2.5 mg/dL) function
  • Patient diagnosed with a compromised immune system or autoimmune disease (WBC count less than 4000/uL or greater than 20,000/uL)
  • Patients undergoing cranial procedures involving petrous bone drilling
  • Patients with traumatic injuries to the head or dural disease in planned dural closure area
  • Patients who are pregnant or lactating
  • Patient with an active infection
  • Patient is undergoing cranial procedures involving non-autologous duraplasty material that are not collagen based
  • Patients requiring re-opening of planned surgical area within 90 days after surgery.
  • Patient with a known allergy to FD\&C Blue #1 dye
  • Patient is not able to tolerate multiple Valsalva maneuvers, or transient elevation of CSF pressure during Valsalva maneuvers is not possible (e.g. the presence of a temporary or permanent CSF shunt
  • Presence of hydrocephalus
  • Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of >9% despite standard diabetes care),
  • Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT>37 seconds or INR >1.5 units)
  • Patient is not likely to comply with the follow-up evaluation schedule.
  • Contraindications to both an MRI and CT scan.
  • Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy. (Observational studies on FDA approved products are not applicable)
  • Patients diagnosed with Meningiomatosis (multiple meningiomas)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 8 центров
  • Keck Medical Center at USC — Los Angeles
  • Mayo Clinic — Jacksonville
  • Tampa General Hospital — Tampa
  • Augusta University — Augusta
  • Brigham and Women's Hospital — Boston
  • Mayo Clinic — Rochester
  • Jacobs Institute — Buffalo
  • Prisma Health — Greenville

Идентификаторы

NCT: NCT06406790 · PRA-CT-0003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗