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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 Randomisiert

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Die klinische Studie NCT07498374 ist eine interventionsstudie zur Untersuchung von Eosinophilic Chronic Rhinosinusitis With Nasal Polyps und hat den Status offene rekrutierung. Die Studie startete am 21. Januar 2026 und soll 192 Teilnehmer aufnehmen. Durchgeführt von Tang-Du Hospital ist der Abschluss für 31. Dezember 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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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Offizieller Titel

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

Erkrankungen
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Weitere Studien-IDs
  • K202601-20
NCT-Nummer
NCT07498374
Studienbeginn (tatsächlich)
2026-01-21
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2028-12-31
Geplante Rekrutierung
192
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
eosinophilic chronic rhinosinusitis with nasal polyps
fully degradable sinus drug-eluting stent
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives Vergleichspräparatthe 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.
Aktives Vergleichspräparatthe 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.
Orale Kortikosteroide
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
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
Verantwortliche Partei
Tangdu Hospital, Hauptprüfer, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital
Zentrale Studienkontakte
Kontakt: Bian Ka, +86 138 9198 2915, [email protected]
1 Studienstandorte in 1 Ländern

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, Kontakt, +86 138 9198 2915, [email protected]
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