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임상시험 NCT07498374은(는) Eosinophilic Chronic Rhinosinusitis With Nasal Polyps에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
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 무작위 배정
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임상시험 NCT07498374은(는) Eosinophilic Chronic Rhinosinusitis With Nasal Polyps에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2026년 1월 21일에 시작되어 192명의 참여자를 모집하고 있습니다. Tang-Du Hospital이(가) 진행하며, 2028년 12월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
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...
더 보기공식 제목
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
질환명
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps기타 연구 식별자
- K202601-20
NCT 번호
실제 연구 시작일
2026-01-21
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2028-12-31
계획된 등록 인원
192
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
eosinophilic chronic rhinosinusitis with nasal polyps
fully degradable sinus drug-eluting stent
fully degradable sinus drug-eluting stent
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군the 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. |
활성 대조군the 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. 경구 코르티코스테로이드 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. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Age 18-65 years.
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
- 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).
- 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.
- Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.
- Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment.
- Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
- Severe systemic disease contraindicating surgery.
- Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
- Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
- 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.
- Recent acute sinusitis episode.
- Physical obstruction preventing access to any ethmoid sinus for stent delivery.
- Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
- Pregnant or lactating women.
- Participation in another clinical trial within the past 1 month.
Part B
Inclusion Criteria:
- Age 18-65 years.
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
- 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).
- 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.
- Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.
Exclusion Criteria:
- Postoperative polyp recurrence in ECRSwNP patients, with any side NPS > 0.
- Use of oral corticosteroids after the last FESS procedure.
- Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
- Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
- Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
- 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.
- Recent acute sinusitis episode.
- Physical obstruction preventing access to any ethmoid sinus for stent delivery.
- Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
- Pregnant or lactating women.
Tang-Du Hospital연구 책임자
Tangdu Hospital, 책임연구자, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital
연구 대표 연락처
연락처: Bian Ka, +86 138 9198 2915, [email protected]
1 1개국에 임상시험 장소
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, 연락처, +86 138 9198 2915, [email protected]
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