Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New dissolvable stent could keep nasal polyps away after surgery

NCT ID NCT07498374

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 192 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Eosinophilic chronic rhinosinusitis with nasal polyps are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China.

    RECRUITING

    Xi'an, Shaanxi, 710038, China