Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Sino-Nasal Outcome Test Scores (SNOT-22)
研究概览
简要总结
Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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,
研究组 & 干预措施
Steroid-eluting Sinus Implant
In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily
干预措施: steroid-eluting sinus stent implant (Procedure)
Steroid-eluting Sinus Implant
In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily
干预措施: saline irrigations (Drug)
Steroid-eluting Sinus Implant
In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily
干预措施: Placebo (Drug)
Control
In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily
干预措施: Systemic glucocorticoids (Drug)
Control
In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily
干预措施: saline irrigations (Drug)
Control
In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily
干预措施: sham procedure (Procedure)
结局指标
主要结局
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
时间窗: Change from Baseline to Week 4
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.
次要结局
- Rescue medication use(Week 4 and Week 12)
- The rate of surgery rate(Week 4 and Week 12)
- Change in Sino-Nasal Outcome Test Scores (SNOT-22)(Change from Baseline to Week 1, 2, 8, 12)
- Change in nasal symptoms(Change from Baseline to Week 1, 2, 4, 8, 12)
- Lund-Kennedy Scoring for Nasal Endoscopy(Change from Baseline to Week 1, 2, 4)
研究者
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery; Deputy Dean of Tongji Medical College; Deputy Dean of Tongji Hospital of Tongji Medical College
Huazhong University of Science and Technology