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El ensayo clínico NCT07498374 para Eosinophilic Chronic Rhinosinusitis With Nasal Polyps está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Efficacy and Safety of Fully Resorbable Sinus Drug-eluting Stents in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps After Surgery: A Prospective, Randomized Controlled Trial 192 Aleatorizado

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El ensayo clínico NCT07498374 es un estudio intervencionista para Eosinophilic Chronic Rhinosinusitis With Nasal Polyps. Su estado actual es: reclutando. El estudio se inició el 21 de enero de 2026, con el objetivo de reclutar a 192 participantes. Dirigido por Tang-Du Hospital, se espera que finalice el 31 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
This study consists of two parts evaluating the efficacy and safety of a fully degradable sinus drug-eluting stent in patients with eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP).

Part A assesses the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery (FESS).

Part B evaluates the stent in patients with early postoperative recurrence of ECRSwNP.

The stud...

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Título oficial

Efficacy and Safety of Fully Resorbable Sinus Drug-eluting Stents in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps After Surgery: A Prospective, Randomized Controlled Trial

Condiciones médicas
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Otros ID del estudio
  • K202601-20
Número del NCT
NCT07498374
Inicio del estudio (real)
2026-01-21
Última actualización
2026-03-27
Fecha de finalización (estimada)
2028-12-31
Inscripción (prevista)
192
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
eosinophilic chronic rhinosinusitis with nasal polyps
fully degradable sinus drug-eluting stent
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador activothe efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery
the fully degradable sinus stent
The intervention is a fully degradable sinus drug-eluting stent system. The stent will be implanted into the bilateral targeted sinus cavities of the participants. Part A Cohort: The stent is placed immediately following Functional Endoscopic Sinus Surgery (FESS). Part B Cohort: The stent is placed when participants are assessed to be in a state of early postoperative recurrence.
intranasal corticosteroids
This is the intervention for the drug comparator group in Part A. Participants will administer a prescribed dose of intranasal corticosteroid spray daily via bilateral nasal application according to the protocol.
Comparador activothe stent in patients with early postoperative recurrence of ECRSwNP
the fully degradable sinus stent
The intervention is a fully degradable sinus drug-eluting stent system. The stent will be implanted into the bilateral targeted sinus cavities of the participants. Part A Cohort: The stent is placed immediately following Functional Endoscopic Sinus Surgery (FESS). Part B Cohort: The stent is placed when participants are assessed to be in a state of early postoperative recurrence.
Corticosteroides orales
This is the intervention for the drug comparator group in Part B. Participants will receive a prescribed course of oral corticosteroids as needed based on clinical assessment and upon signs of early postoperative recurrence, in accordance with the study protocol.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Part A: Median Time to Early Polyp/Edema Recurrence Within 6 Months
The median time to the development of early polyp recurrence and/or edema (defined as polypoid change or a Lund-Kennedy edema score ≥ 1) within 6 months post-treatment.
From treatment initiation up to 6 months.
Part A: Incidence Rate of Early Polyp/Edema Recurrence at Each Visit
The proportion of patients presenting with early polyp recurrence and/or edema (defined as polypoid change or a Lund-Kennedy edema score ≥ 1) at each scheduled visit (Week 2, 4, 8, 12, and Month 6).
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:Lund-Kennedy Endoscopic Score and Change from Baseline
Lund-Kennedy endoscopic score at each scheduled visit and its change from the baseline score (at the time of early recurrence diagnosis/treatment initiation).
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Part A:Lund-Kennedy Endoscopic Score and Change from Baseline
Lund-Kennedy endoscopic score (assessing polyps, edema, discharge, scarring, and crusting) at each visit and its change from the baseline (post-operative) score.
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:SNOT-22 Score and Change from Baseline
Sino-Nasal Outcome Test-22 (SNOT-22) score (a patient-reported outcome measure of symptom severity and quality of life impact) at each visit and its change from the baseline score.
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:Time to and Proportion of Complete Mucosal Re-epithelialization
The time to first observed complete re-epithelialization of the nasal mucosa post-surgery, and the proportion of patients achieving it during the study period.
From treatment initiation up to 6 months.
Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use
The time from treatment initiation to the first requirement of systemic corticosteroids for symptom control, and the total cumulative duration of systemic corticosteroid use during the 6-month period.
From treatment initiation up to 6 months.
Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery
The proportion of patients who undergo revision surgery or meet the criteria for revision surgery (defined as an endoscopic Nasal Polyp Score ≥ 2 in any unilateral sinus) at each visit.
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:SNOT-22 Score and Change from Baseline
Sino-Nasal Outcome Test-22 (SNOT-22) score at each visit and its change from the baseline score.
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:Time to and Proportion of Complete Mucosal Re-epithelialization
The time to first observed complete re-epithelialization of the nasal mucosa following treatment for early recurrence, and the proportion of patients achieving it.
From treatment initiation up to 6 months.
Part B:Cumulative Dose of Systemic Corticosteroids
The total cumulative dose of systemic corticosteroids used for symptom control during the 6-month treatment period in each group.
From treatment initiation up to 6 months.
Part B: Proportion of Patients Requiring or Meeting Criteria for Revision Surgery
The proportion of patients who undergo revision surgery or meet the criteria for revision surgery (defined as an endoscopic Nasal Polyp Score ≥ 2 in any unilateral sinus) at each visit.
Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Part A
  1. Age 18-65 years.
  2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
  3. Eosinophilic subtype confirmed by pathology (eosinophils >27% of total infiltrating inflammatory cells in polyp tissue, OR absolute count >55 eosinophils per high-power field (HPF) on H&E staining).
  4. Indicated and scheduled for Functional Endoscopic Sinus Surgery (FESS) due to inadequate response to standard medical therapy for >3 months, with bilateral endoscopic Nasal Polyp Score (NPS) ≥5 (max 8), each side ≥2, and presenting at least 2 of the following symptoms before screening: nasal blockage/congestion, anterior/posterior nasal discharge, facial pain/pressure, or reduced/loss of smell.
  5. Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.

  1. Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment.
  2. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
  3. Severe systemic disease contraindicating surgery.
  4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
  5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
  6. Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
  7. Recent acute sinusitis episode.
  8. Physical obstruction preventing access to any ethmoid sinus for stent delivery.
  9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
  10. Pregnant or lactating women.
  11. Participation in another clinical trial within the past 1 month.

Part B

Inclusion Criteria:

  1. Age 18-65 years.
  2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
  3. Eosinophilic subtype confirmed by pathology (eosinophils >27% of total infiltrating inflammatory cells in polyp tissue, OR absolute count >55 eosinophils per high-power field (HPF) on H&E staining).
  4. Early recurrence state: >3 months post-FESS with standard therapy, no polyps (NPS=0), Lund-Kennedy (LK) edema score ≥2, and LK discharge score ≥2.
  5. Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.

Exclusion Criteria:

  1. Postoperative polyp recurrence in ECRSwNP patients, with any side NPS > 0.
  2. Use of oral corticosteroids after the last FESS procedure.
  3. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
  4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
  5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
  6. Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
  7. Recent acute sinusitis episode.
  8. Physical obstruction preventing access to any ethmoid sinus for stent delivery.
  9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
  10. Pregnant or lactating women.
Tang-Du Hospital logoTang-Du Hospital
Parte responsable del estudio
Tangdu Hospital, Investigador principal, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital
Contactos centrales del estudio
Contacto: Bian Ka, +86 138 9198 2915, [email protected]
1 Centros del estudio en 1 países

Shaanxi

Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China., Xi'an, Shaanxi, 710038, China
Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi bianka, Contacto, +86 138 9198 2915, [email protected]
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