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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2026-04-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were biodegradation at Week 4 to allow blinded assessment of bilateral edema score grade.

Study Groups

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Steroid-eluting Sinus Implant

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

Group Type EXPERIMENTAL

steroid-eluting sinus stent implant

Intervention Type PROCEDURE

In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia

saline irrigations

Intervention Type DRUG

Patients were routinely treated with saline irrigations (250ml) twice daily

Placebo

Intervention Type DRUG

Groups were given systemic glucocorticoid placebo

Control

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

Group Type SHAM_COMPARATOR

Systemic glucocorticoids

Intervention Type DRUG

Groups were given oral methylprednisolone (32 mg/d on days 1-5; 16 mg/d on days 6-10; and 8 mg/d on days 11-20),

saline irrigations

Intervention Type DRUG

Patients were routinely treated with saline irrigations (250ml) twice daily

sham procedure

Intervention Type PROCEDURE

The sham procedure was performed in-office under local anesthesia

Interventions

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steroid-eluting sinus stent implant

In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia

Intervention Type PROCEDURE

Systemic glucocorticoids

Groups were given oral methylprednisolone (32 mg/d on days 1-5; 16 mg/d on days 6-10; and 8 mg/d on days 11-20),

Intervention Type DRUG

saline irrigations

Patients were routinely treated with saline irrigations (250ml) twice daily

Intervention Type DRUG

Placebo

Groups were given systemic glucocorticoid placebo

Intervention Type DRUG

sham procedure

The sham procedure was performed in-office under local anesthesia

Intervention Type PROCEDURE

Other Intervention Names

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BISORB bioabsorbable steroid-eluting sinus stent Medrol 0.9% sodium chloride solution Systemic glucocorticoid placebo In-office bilateral sham procedure of stent placement

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No