Xiangtong TM Full Degradation Sinus Drug Stent System Prospective, Open, Single-center, Randomized Controlled Clinical Trial

Официальное название

Efficacy and Safety of Xiangtong TM Full Degradation Sinus Drug Stent System

Обзор

Xiangtong® Fully Degradable Sinus Drug Stent System is a high-tech medical device independently developed by Puyi Bio, specially designed for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS).The product is implanted into the target site during and after surgery, which not only supports the separation of the wound and fixes the repaired mucosal flap, but also controls edema, prevents adhesions, maintains smooth drainage, and sustains the target site to fight against inflammation and promotes healing by means of slow-release hormones.

Вмешательства

• Устройство Xiangtong TM full degradation sinus drug stent system
  use Xiangtong TM full degradation sinus drug stent system to deliver drugs into sinus
• Устройство nasopore
  use nasopore to protect the post-operative sinus

Первичные конечные точки

• Postoperative reintervention rates based on imaging evaluations [Срок оценки: 30 days after operation]

Критерии участия

Критерии включения

• Subjects are 18-65 years of age, male or non-pregnant female. The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs an informed consent form.

Subjects must meet the diagnostic guidelines for chronic rhinosinusitis, have a confirmed diagnosis of bilateral chronic rhinosinusitis, and have a CT scan confirming bilateral Lund-Mackay scores >6 (CT scan within 3 months prior to surgery is valid).

• Female subjects who are not breastfeeding at the time of the screening visit and who do not plan to breastfeed or become pregnant for up to one year after the starting point.
• Subject has not participated in another clinical trial in the previous 3 months and agrees not to participate in another clinical trial until the endpoints of this trial have been met.

Критерии исключения

• Subject has a known allergic reaction or contraindication to the device material and its degradation products (mometasone acid, levulinic acid, racemic polylactic acid, propyl lactate, lactic acid).
• The subject is on long-term oral hormonal medications.
• The subject is receiving immunosuppressive therapy or has a known immunosuppressive or autoimmune disease: the subject has diabetes mellitus.
• The subject has or has had glaucoma or high intraocular pressure.
• The subject has cataracts.
• The subject has an artificial eye.
• Acute bacterial sinusitis and acute fungal sinusitis.
• Subject has a life expectancy of less than 12 months.
• Subject has participated in a clinical trial of another drug or device that did not meet the primary study endpoint: Subject is unable or unwilling to participate in this trial.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06669130 · 2024-SR-350

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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