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Lo studio clinico NCT07498374 per Eosinophilic Chronic Rhinosinusitis With Nasal Polyps è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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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 Randomizzato

In arruolamento
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La sperimentazione clinica NCT07498374 è uno studio interventistico per Eosinophilic Chronic Rhinosinusitis With Nasal Polyps, attualmente in arruolamento. Avviato il 21 gennaio 2026, prevede di arruolare 192 partecipanti. Sotto la guida di Tang-Du Hospital, dovrebbe concludersi entro il 31 dicembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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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Titolo ufficiale

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

Patologie
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Altri ID dello studio
  • K202601-20
Numero NCT
NCT07498374
Data di inizio (effettiva)
2026-01-21
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2028-12-31
Arruolamento (previsto)
192
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
eosinophilic chronic rhinosinusitis with nasal polyps
fully degradable sinus drug-eluting stent
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivothe 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.
Comparatore attivothe 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.
Corticosteroidi orali
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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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.
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
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 responsabile dello studio
Tangdu Hospital, Investigatore principale, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital
Contatti principali dello studio
Contatto: Bian Ka, +86 138 9198 2915, [email protected]
1 Centri dello studio in 1 paesi

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, Contatto, +86 138 9198 2915, [email protected]
In arruolamento