Набор по приглашению NCT07286201
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate (MF)
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: OCEAN, Steroid-eluting sinus stent.
- Кому может быть актуально
- Состояния в реестре: Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps. 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, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent
Обзор
The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting sinus stent.
Подробное описание
A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.
Вмешательства
- Устройство OCEAN
Biodegradable nasal dressing applied after sinus/nasal surgery - Устройство Steroid-eluting sinus stent
Applied after sinus/nasal surgery
Первичные конечные точки
- Rate of Serious Adverse Events [Срок оценки: Up to Day 25]
- Endoscopic Assessment [Срок оценки: Day 25]
Вторичные конечные точки (3)
- Rate of Adverse Events [Срок оценки: Up to Day 90]
- Endoscopic Evaluation of Sinonasal Cavities [Срок оценки: Days 25 and 90]
- Rate of post-operative interventions [Срок оценки: Up to Day 25 and Day 90]
Критерии участия
Критерии включения
- Subject is 18 years or older
- Subject is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitus with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP) and is indicated for bilateral complete ethmoidectomy (anterior and posterior ethmoidectomy) at a minimum. Additional sinuses may be operated on at the surgeon's discretion.
- Subject is willing and able to provide informed consent.
- Subject is willing and able to comply with the investigational plan requirements.
- Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril).
- Subject with a pre-operative Lund-Mackay stage side-to-side difference ≤ 2.
- Subject of child-bearing potential is not pregnant and agrees to not become pregnant during the course of the study.
Критерии исключения
- Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides).
- Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin.
- Subject with a known or suspected allergy to device components.
- Subject with known hemophilia.
- Subject with insulin dependent diabetes.
- Subject with an oral steroid dependent condition.
- Subject with glaucoma, ocular hypertension, posterior subcapsular cataracts.
- Subject with a (previous) diagnosis of Samter's Triad (AERD).
- Subject that requires nasal ointments or creams at time of device placement.
- Subject with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data.
- Subject with plans to (or otherwise anticipate the need to) undergo an ENT procedure within the 90-day study follow-up.
- Subject participating in another clinical research study (within 30 days prior to screening up to 90 days post-operative).
- Subject that used any form of biologics within 90 days prior to sinus surgery and during follow-up to day 25.
- Subject that used any form of corticosteroid within 2 weeks prior to sinus surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 9 центров
- Colorado ENT & Allergy — Colorado Springs
- Emory University — Atlanta
- University of Illinois at Chicago — Chicago
- Louisiana State University Health at Shreveport — Shreveport
- Centers for Advanced ENT Care — Towson
- Medical University of South Carolina — Charleston
- University of Texas Health — Houston
- Ogden Clinic — Ogden
- … и ещё 1 центр
Идентификаторы
NCT: NCT07286201 · CIP-6