Steroid-eluting sinus stent for chronic sinusitis patients with ongoing symptoms

Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

This study is testing a new type of sinus stent that releases medicine to see if it helps people with ongoing symptoms of chronic sinusitis feel better after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06198894 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a steroid-eluting sinus stent in 96 patients suffering from chronic rhinosinusitis who have uncontrolled postoperative symptoms. The study is randomized, sham-controlled, and multicenter, comparing the stent's performance against systemic glucocorticoids. The stent, which is bioabsorbable and coated with mometasone furoate, is designed to release medication directly to the sinus mucosa over a 30-day period. Participants will receive the stent in-office under local anesthesia, and their outcomes will be assessed using established clinical criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who have undergone prior endoscopic sinus surgery and continue to experience uncontrolled symptoms.

Not a fit: Patients with significant nasal polyps or those with known allergies to the stent materials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a targeted treatment option for patients with chronic rhinosinusitis, potentially improving their quality of life.

How similar studies have performed: While the use of steroid-eluting stents is a relatively novel approach, similar studies have shown promise in improving outcomes for patients with chronic sinus conditions.

Eligibility criteria

Inclusion Criteria:

* The patient underwent pre-functional endoscopic sinus surgery and bilateral ethmoidectomy (for at least 3 months), and was identified by the clinician as having uncontrolled symptoms (Diagnostic criteria of EPOS 2020) with a Snot-22 score of at least 20;
* Edema score of bilateral nasal endoscopy was 2 points both;
* Understands the purpose and procedures of the trial and voluntarily signs the informed consent form;
* The female subjects had no pregnancy or lactation plans during the treatment and follow-up period;
* The subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials until the end point of this trial was reached;
* Subjects were 18-65 years old, male or non-pregnant women;

Exclusion Criteria:

* Grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extending beyond the middle nasal passage)
* The subject has a known allergic reaction or contraindication to the device material and its degradation products (mamethasone citrate, L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid);
* Subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globular sinusitis, systemic vasculitis and granulomatous diseases, tumors, and immune deficiency.
* The patient underwent endoscopic nasal surgery within 3 months.
* Acute exacerbation of allergic rhinitis, acute exacerbation of CRS, upper respiratory tract infection, or common cold in the 4 weeks prior to screening visit;
* Have a clinically serious metabolic, cardiovascular, immune, neurological, blood, digestive, cerebrovascular, or respiratory disease, or any condition that the investigator believes interferes with the evaluation of the study results or affects the safety of the subjects;
* Symptomatic seasonal allergic rhinitis, and/or, depending on the season, expected to develop symptoms and require nasal spray hormone therapy within 4 weeks of randomization,

Where this trial is running

Wuhan, Hubei

• Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Zheng Liu

Conditions Chronic Sinusitis; steroid-eluting sinus stent; mucous edema