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

Last updated: January 17, 2024
Sponsor: Zheng Liu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rhinitis, Allergic, Perennial

Sinus Infections

Sinusitis

Treatment

Placebo

Systemic glucocorticoids

sham procedure

Clinical Study ID

NCT06198894
Stent-001
  • Ages 18-65
  • All Genders

Study Summary

Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extendingbeyond the middle nasal passage)
  • The subject has a known allergic reaction or contraindication to the device materialand its degradation products (mamethasone citrate, L-polylactic acid, racemicpolylactic acid, lactide lactate, lactic acid);
  • Subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globularsinusitis, systemic vasculitis and granulomatous diseases, tumors, and immunedeficiency.
  • The patient underwent endoscopic nasal surgery within 3 months.
  • Acute exacerbation of allergic rhinitis, acute exacerbation of CRS, upper respiratorytract 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 theinvestigator believes interferes with the evaluation of the study results or affectsthe safety of the subjects;
  • Symptomatic seasonal allergic rhinitis, and/or, depending on the season, expected todevelop symptoms and require nasal spray hormone therapy within 4 weeks ofrandomization,

Study Design

Total Participants: 96
Treatment Group(s): 5
Primary Treatment: Placebo
Phase:
Study Start date:
January 10, 2024
Estimated Completion Date:
April 10, 2026

Study Description

Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study in 96 chronic rhinosinusitis patients who had prior endoscopic sinus surgery and presented with uncontrolled postoperative symptoms. The objective was to evaluate the safety and clinical efficacy of sinus stents relative to systemic glucocorticoids. The steroid-eluting sinus stent consist of a bioabsorbable self-expanding sinus implant coated with 625 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the sinus stent implant provides controlled release of MF to the sinus mucosa over 30 days.

Connect with a study center

  • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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