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

Zheng Liu

Status: Enrolling

Conditions: Chronic Sinusitis

Treatments: Procedure: sham procedure; Procedure: steroid-eluting sinus stent implant; Drug: saline irrigations; Drug: Placebo; Drug: Systemic glucocorticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT06198894

Stent-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Steroid-eluting Sinus Implant

Experimental group

Description:

In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily

Treatment:

Drug: Placebo

Drug: saline irrigations

Procedure: steroid-eluting sinus stent implant

Control

Sham Comparator group

Description:

In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily

Treatment:

Drug: Systemic glucocorticoids

Drug: saline irrigations

Procedure: sham procedure