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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 study aims to answer the following key questions:
Does the use of the stent reduce the recurrence of nasal polyps?
Can the stent reduce the need for oral corticosteroids?
The fully degradable sinus drug-eluting stent is compared with intranasal corticosteroids (Part A) and oral corticosteroids (Part B) to determine whether it offers therapeutic benefit in the management of ECRSwNP.
Participant Procedures:
Part A: Participants will either receive the fully degradable sinus stent or daily intranasal corticosteroids for 6 months. Follow-up visits will occur at Week 2, Week 4, Week 8, Week 12, and Month 6 to record symptoms and adverse events.
Part B: Participants will either receive the fully degradable sinus stent or oral corticosteroids (based on disease progression) for 6 months. Follow-up visits will be conducted at Week 2, Week 4, Week 8, Week 12, and Month 6 for symptom assessment and documentation of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery | Active Comparator |
| |
| the stent in patients with early postoperative recurrence of ECRSwNP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the fully degradable sinus stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Part A
Inclusion Criteria:
Exclusion Criteria:
Part B
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bian Ka | Contact | +86 138 9198 2915 | kabia@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China. | Recruiting | Xi'an | Shaanxi | 710038 | China |
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|
| intranasal corticosteroids | Drug | 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. |
|
| oral corticosteroids | Drug | 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. |
|
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. |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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