Eosinophilic Chronic Rhinosinusitis With Nasal PolypsNCT07498374
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
A study testing the fully degradable sinus stent, intranasal corticosteroids and oral corticosteroids in people with Eosinophilic Chronic Rhinosinusitis With Nasal Polyps, run by Tang-Du Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- the fully degradable sinus stent, intranasal corticosteroids and oral corticosteroids
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age 18-65 years.
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- 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.
Who cannot join
- 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.
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- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China.
Xi'an, Shaanxi, 710038
Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi bianka, +86 138 9198 2915, kabian@fmmu.edu.cn
About this study
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).
Read more
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.
- Being tested
- the fully degradable sinus stent, intranasal corticosteroids, oral corticosteroids
- Keywords
- eosinophilic chronic rhinosinusitis with nasal polyps, fully degradable sinus drug-eluting stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the fully degradable sinus stentDevice
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 corticosteroidsDrug
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 corticosteroidsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery | Active comparator | Not described Receives: Device: the fully degradable sinus stent; Drug: intranasal corticosteroids |
| the stent in patients with early postoperative recurrence of ECRSwNP | Active comparator | Not described Receives: Device: the fully degradable sinus stent; Drug: oral corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start21 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tangdu Hospital, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498374
- Sponsor's protocol ID
- K202601-20
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07498374
- Acronym / sponsor ID
- K202601-20
- Keywords
- eosinophilic chronic rhinosinusitis with nasal polyps, fully degradable sinus drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery | Active comparator | Device: the fully degradable sinus stent, Drug: intranasal corticosteroids |
| the stent in patients with early postoperative recurrence of ECRSwNP | Active comparator | Device: the fully degradable sinus stent, Drug: oral corticosteroids |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the fully degradable sinus stentThe 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. | Device | the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery, the stent in patients with early postoperative recurrence of ECRSwNP |
| intranasal corticosteroidsThis 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. | Drug | the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery |
| oral corticosteroidsThis 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. | Drug | the stent in patients with early postoperative recurrence of ECRSwNP |
Primary outcome
Part A: Median Time to Early Polyp/Edema Recurrence Within 6 Months
Time frame: From treatment initiation up to 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.
Part A: Incidence Rate of Early Polyp/Edema Recurrence at Each Visit
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
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).
Part B:Lund-Kennedy Endoscopic Score and Change from Baseline
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Lund-Kennedy endoscopic score at each scheduled visit and its change from the baseline score (at the time of early recurrence diagnosis/treatment initiation).
9 secondary outcomes
Part A:Lund-Kennedy Endoscopic Score and Change from Baseline
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:SNOT-22 Score and Change from Baseline
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:Time to and Proportion of Complete Mucosal Re-epithelialization
Time frame: From treatment initiation up to 6 months.
Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use
Time frame: From treatment initiation up to 6 months.
Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:SNOT-22 Score and Change from Baseline
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:Time to and Proportion of Complete Mucosal Re-epithelialization
Time frame: From treatment initiation up to 6 months.
Part B:Cumulative Dose of Systemic Corticosteroids
Time frame: From treatment initiation up to 6 months.
Part B: Proportion of Patients Requiring or Meeting Criteria for Revision Surgery
Time frame: Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the fully degradable sinus stent, intranasal corticosteroids and oral corticosteroids in people with Eosinophilic Chronic Rhinosinusitis With Nasal Polyps, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bian Ka (+86 138 9198 2915, kabia@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Median Time to Early Polyp/Edema Recurrence Within 6 Months (time frame: From treatment initiation up to 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.