Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Официальное название

A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects

Обзор

This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).

Подробное описание

Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.

Вмешательства

• Комбинированный продукт Airiver ESSpand DCB
  The investigational procedure will be ESSpand DCB dilation of all surgically treated sinuses, including the resected ethmoid sinus cavities. Note: Prior to randomization to the investigational procedure, all subjects will undergo traditional ESS of their diseased sinuses.
• Процедура ESS
  traditional ESS treatment of diseased sinuses.

Первичные конечные точки

• Primary safety [Срок оценки: 30 days post- index procedure]
• Primary efficacy endpoint [Срок оценки: 6 months post-index procedure]

Вторичные конечные точки (2)

• Hypothesis tested clinical responder rate at 12 months [Срок оценки: 12 months]
• Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Male or female, aged ≥18 years
• Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
• Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
• Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
• Baseline SNOT-22 score ≥ 30
• Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
• Willing and able to provide written informed consent
• Willing and able to comply with all protocol follow up visits and assessments

Критерии исключения

• Nasal cavity tumor (malignant or benign)
• Antrochoanal polyps
• Previous complete middle turbinate resection
• Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
• History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
• Concurrent condition requiring active chemotherapy and/or immunotherapy management
• Subjects whose symptoms are too severe to undergo ESS (e.g., temperature >102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
• History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
• History of primary ciliary dyskinesia
• Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
• Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
• Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.
• Allergy or hypersensitivity to paclitaxel or structurally related compounds.
• Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.
• Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.
• Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.
• Subject has a history of inability to tolerate nasal endoscopy
• Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
• Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
• Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.
• Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.
• Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
• Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents.
• Subject whose study index procedure is aborted for any reason
• Life expectancy <2 years

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 10 центров

• Excel ENT — Birmingham
• SENTA Clinica — San Diego
• Colorado ENT & Allergy — Colorado Springs
• Physicians' Clinic of Iowa — Cedar Rapids
• Advanced ENT — Louisville
• University of Pennsylvania — Philadelphia
• Charleston ENT & Allergy — Charleston
• MUSC - Medical University of South Carolina — Charleston
• … и ещё 2 центра

Идентификаторы

NCT: NCT07290140 · PR3056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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