Safety and Efficacy Evaluation of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

Официальное название

A Multiple Center, Prospective, Single-arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of ArtiFix® Sealant Graft in Subjects Requiring Dural Repair Following Neurosurgery

Обзор

The purpose of this clinical study is to evaluate and establish the safety and efficacy of the ArtiFix® device in subjects scheduled for cranial or spinal surgery that requires Dural repair (membrane that covers the brain and spinal cord). The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 30, 120 and 330 days after the procedure.

Вмешательства

• Устройство ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries.
  ArtiFix® is a synthetic surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. ArtiFix® adheres to the dura, so that sutures are not required to prevent cerebrospinal fluid (CSF) leakage.

Первичные конечные точки

• Evaluation of CSF leakage rate up to 120 days after ArtiFix® implantation. [Срок оценки: up to 120 days after ArtiFix® implantation]

Вторичные конечные точки (5)

• Evaluation of CSF leakage rate via MRI at 120 days after ArtiFix® implantation Evaluation of CSF leakage rate via MRI at 330 days after ArtiFix® implantation [Срок оценки: at 120 and 330 days after ArtiFix® implantation.]
• To evaluate the frequency and severity of device-related adverse events, up to 330 days post ArtiFix® implantation. [Срок оценки: up to 330 days post ArtiFix® implantation.]
• Wound healing at implant site up to 30 days after implantation. [Срок оценки: Up to 30 days after implantation.]
• Device Handling Characteristics, as reported by the surgeon [e.g. Ease of Use, Strength, Seal Quality, Reapplication (if occurred), adhesion to surgical tools]. Device Handling Characteristics reported by user experience questionnaire. [Срок оценки: Following investigational device implantation on the day of the surgical procedure.]
• Magnetic Resonance Imaging at the 120 and 330 days follow-up, to determine the presence or absence of the following conditions: • Adhesion formation • Scarring • Brain edema adjacent to device implant site [Срок оценки: At the 120 and 330 days follow-up visits]

Критерии участия

Критерии включения

• Subject between the ages of 22-65 (inclusive)
• Subject is scheduled for an elective cranial or spinal surgery with a single dural defect that could not be completely repaired by primary suture. The dural defect must not exceed 6cm2 (e.g. defects of sizes 2cm X 3cm, 1cm X 5cm, can be included). The defect can be completely repaired/closed by a dural sealant graft with an overlap of 6 mm with the surrounding intact dura (only 1 graft can be implanted in each subject in a single location).
• Subject has undergone imaging (such as, CT or MRI) in the past 6 months before enrolment.
• Surgical wound is expected to be Class I/clean.
• Subject understands the study requirements and procedures, can provide written Informed Consent and is able and willing to adhere to the required follow-up visits and testing.

Критерии исключения

• Subject has known hydrocephalus.
• Subject is unable to undergo MRI after the surgery.
• Subject's life expectancy is less than 12 months.
• Significant intraoperative hemorrhage that mandates blood transfusion.
• Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia etc.) or evidence of any surgical site infection, fever > 38.3°C, positive blood culture and/or a positive chest x-ray for acute inflammatory process.
• Subject has acquired or congenital compromised immune system and/or autoimmune disease, and/or is taking chronic immunosuppressant agents at baseline.
• Subject will require use of other forms of dural repair (i.e. dural graft or sealant).
• Subject is intended to undergo craniectomy wherein bone flap will not be returned.
• Subject with a compromised wound healing process due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other concurrent conditions (e.g. long-standing steroids treatment).
• Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C>6.5%), sepsis, and systemic collagen disease.
• Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.
• Subject is an acute cranial trauma surgical case or had intracranial hemorrhage from any cause (hemorrhagic stroke, ruptured aneurysm etc.).
• Subject that has a concurrent disease or symptoms or conditions that would place the patient in excessive risk to the planned surgery - defined by PI.
• Subject had a previous neurosurgery in the same anatomical site.
• Subject was diagnosed with clinically significant coagulopathy as determined by the surgeon.
• Subject is participating in another clinical trial using investigational devices/drugs
• Subjects who previously participated in any investigational drug or device study within 30 days of screening
• Subject has known history of sensitivity or allergy to any component of the ArtiFix®.
• Female subjects who are breastfeeding, pregnant or interested in becoming pregnant during the duration of the study.
• Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07092267 · CLN-02-1026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗