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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 無作為化

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治験番号 NCT07498374 は 介入研究 臨床試験 で、Eosinophilic Chronic Rhinosinusitis With Nasal Polyps に関するものです。現在は 募集中 で、2026年1月21日 から開始しています。192 名の参加者 の募集が計画されています。この試験は Tang-Du Hospital によって主導され、2028年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
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.

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公式タイトル

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

疾患名
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
その他の研究識別子
  • K202601-20
NCT番号
NCT07498374
開始日
2026-01-21
最終更新日
2026-03-27
終了予定日
2028-12-31
目標参加者数
192
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
eosinophilic chronic rhinosinusitis with nasal polyps
fully degradable sinus drug-eluting stent
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実薬対照薬the 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.
実薬対照薬the 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.
経口コルチコステロイド
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.
主要評価項目
評価指標指標の説明時間枠
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.
副次評価項目
評価指標指標の説明時間枠
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.
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
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
責任者
Tangdu Hospital, 主任研究者, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital
試験中央連絡先
連絡先: Bian Ka, +86 138 9198 2915, [email protected]
1 1カ国の場所

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, 連絡先, +86 138 9198 2915, [email protected]
募集中