An interventional study of steroid-eluting sinus stent implant and Systemic glucocorticoids in Chronic Sinusitis, sponsored by Zheng Liu. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Zheng Liu · Not applicable, Interventional, and Treatment
Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms
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.
256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.
This study's planned enrollment of 96 is above the median of 60 across 196 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Zheng Liu is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily
Procedure: steroid-eluting sinus stent implant · Drug: saline irrigations · Drug: Placebo
In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily
Drug: Systemic glucocorticoids · Drug: saline irrigations · Procedure: sham procedure
In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia
Also known as: BISORB bioabsorbable steroid-eluting sinus stent
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),
Also known as: Medrol
Patients were routinely treated with saline irrigations (250ml) twice daily
Also known as: 0.9% sodium chloride solution
Groups were given systemic glucocorticoid placebo
Also known as: Systemic glucocorticoid placebo
The sham procedure was performed in-office under local anesthesia
Also known as: In-office bilateral sham procedure of stent placement
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
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.
Time frame: Change from Baseline to Week 4
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
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.
Time frame: Change from Baseline to Week 1, 2, 8, 12
Change in nasal symptoms
Nasal symptoms measured by Visual analog score. The four nasal symptoms (nasal obstruction, rhinorrhea, headache and olfactory disorder) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a10-point scale (0 = no symptoms;10 = most severe symptoms).
Time frame: Change from Baseline to Week 1, 2, 4, 8, 12
Rescue medication use
If polyps and/or the moderate to severe clinical symptoms of CRS were relapsed and/or not controlled throughout the study period, rescue medication of corticosteroids for the experimental group will be used and recorded.
Time frame: Week 4 and Week 12
The rate of surgery rate
The rate of nasal endoscopic surgery for the experimental or control group throughout the study period will be recorded.
Time frame: Week 4 and Week 12
Lund-Kennedy Scoring for Nasal Endoscopy
The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions, and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.
Time frame: Change from Baseline to Week 1, 2, 4
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Zheng Liu