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临床试验 NCT07498374 针对Eosinophilic Chronic Rhinosinusitis With Nasal Polyps目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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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 随机化

招募中
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临床试验NCT07498374是一项针对Eosinophilic Chronic Rhinosinusitis With Nasal Polyps的干预性研究试验，目前试验状态为招募中。试验始于2026年1月21日，计划招募192名患者。该研究由Tang-Du Hospital主导，预计于2028年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月27日。
简要概括
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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官方标题

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

疾病
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
其他研究标识符
  • K202601-20
NCT编号
NCT07498374
实际开始日期
2026-01-21
最近更新发布
2026-03-27
预计完成日期
2028-12-31
计划入组人数
192
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
eosinophilic chronic rhinosinusitis with nasal polyps
fully degradable sinus drug-eluting stent
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
参与者组/试验组干预措施/治疗方法
阳性对照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.
阳性对照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.
口服皮质类固醇
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.
主要终点
结果指标度量标准描述时间框架
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.
次要终点
结果指标度量标准描述时间框架
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.
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
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
研究责任方
Tangdu Hospital, 主要研究者, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital
研究中心联系人
联系人: Bian Ka, +86 138 9198 2915, [email protected]
1 位于 1 个国家/地区的研究中心

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, 联系人, +86 138 9198 2915, [email protected]
招募中