Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Launched by ZHENG LIU · Dec 27, 2023

Keywords

ClinConnect Summary

The Steroid-eluting Sinus Stent trial is studying a new treatment option for adults with chronic sinusitis who continue to have symptoms even after surgery. The trial involves using a special stent that releases steroids to help reduce inflammation in the sinuses. Researchers are looking for 96 participants aged 18 to 65 who have had previous sinus surgery but still experience significant symptoms. To be eligible, participants should have a certain level of nasal swelling and must not have other serious health issues that could interfere with the study.

If you decide to join this trial, you will receive the steroid-eluting stent and be monitored to see how well it works in improving your symptoms. It's important to know that certain conditions, like having severe nasal polyps or recent sinus surgery, might prevent you from participating. The trial is currently recruiting participants, and anyone interested will need to understand the trial's purpose and agree to the terms before signing up. This could be a valuable opportunity to help improve treatment options for chronic sinusitis.

Gender

ALL

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,