New dissolvable stent could keep nasal polyps away after surgery
NCT ID NCT07498374
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special dissolvable stent that releases medicine inside the sinuses after surgery for nasal polyps. The goal is to see if it can stop polyps from coming back and reduce the need for steroid pills or sprays. About 192 adults with a type of nasal polyp linked to allergies will be followed for 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Part A 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. 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. Exclusion Criteria: 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China.
RECRUITINGXi'an, Shaanxi, 710038, China