Chronic SinusitisNCT06198894
Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
A study testing steroid-eluting sinus stent implant, Systemic glucocorticoids and saline irrigations in people with Chronic Sinusitis, run by Zheng Liu at 1 site in China.
Trial summary
Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- steroid-eluting sinus stent implant, Systemic glucocorticoids and saline irrigations
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zheng Liu, doctor, 86 027 83663807, zhengliuent@hotmail.com
Wang, Doctor
About this study
Official title: Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms
Read the detailed 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.
- Conditions
- Chronic Sinusitis
- Being tested
- steroid-eluting sinus stent implant, Systemic glucocorticoids, saline irrigations, Placebo, sham procedure
- Keywords
- steroid-eluting sinus stent, mucous edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid-eluting sinus stent implantProcedure or surgery
Also called BISORB bioabsorbable steroid-eluting sinus stent
In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia
Systemic glucocorticoidsDrug
Also called Medrol
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 irrigationsDrug
Also called 0.9% sodium chloride solution
Patients were routinely treated with saline irrigations (250ml) twice daily
PlaceboDrug
Also called Systemic glucocorticoid placebo
Groups were given systemic glucocorticoid placebo
sham procedureProcedure or surgery
Also called In-office bilateral sham procedure of stent placement
The sham procedure was performed in-office under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Steroid-eluting Sinus Implant | Experimental | In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily Receives: Procedure: steroid-eluting sinus stent implant; Drug: saline irrigations; Drug: Placebo |
| Control | Sham comparator | In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily Receives: Drug: Systemic glucocorticoids; Drug: saline irrigations; Procedure: sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Week 4
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to Week 1, 2, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start10 Jan 2024 (estimated)
- Primary completion10 Jan 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198894
- Sponsor's protocol ID
- Stent-001
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.
PubMed 26992115Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald PJ, Mayr S, Hens G, Hellings P, Ebbens FA, Fokkens W, Van Cauwenberge P, Bachert C. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol. 2010 May;125(5):1069-1076.e4. doi: 10.1016/j.jaci.2010.02.020.
PubMed 20451040
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
- ClinicalTrials.gov ID
- NCT06198894
- Acronym / sponsor ID
- Stent-001
- Conditions
- Chronic Sinusitis
- Keywords
- steroid-eluting sinus stent, mucous edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Zheng LiuUniversity, hospital or other
- Study start
- 10 Jan 2024 (estimated)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Steroid-eluting Sinus Implant | Experimental | Procedure: steroid-eluting sinus stent implant, Drug: saline irrigations, Drug: PlaceboIn-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily |
| Control | Sham comparator | Drug: Systemic glucocorticoids, Drug: saline irrigations, Procedure: sham procedureIn-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroid-eluting sinus stent implantAlso: BISORB bioabsorbable steroid-eluting sinus stentIn-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia | Procedure or surgery | Steroid-eluting Sinus Implant |
| Systemic glucocorticoidsAlso: MedrolGroups 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), | Drug | Control |
| saline irrigationsAlso: 0.9% sodium chloride solutionPatients were routinely treated with saline irrigations (250ml) twice daily | Drug | Control, Steroid-eluting Sinus Implant |
| PlaceboAlso: Systemic glucocorticoid placeboGroups were given systemic glucocorticoid placebo | Drug | Steroid-eluting Sinus Implant |
| sham procedureAlso: In-office bilateral sham procedure of stent placementThe sham procedure was performed in-office under local anesthesia | Procedure or surgery | Control |
Primary outcome
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time frame: 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.
5 secondary outcomes
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
Time frame: Change from Baseline to Week 1, 2, 8, 12
Change in nasal symptoms
Time frame: Change from Baseline to Week 1, 2, 4, 8, 12
Rescue medication use
Time frame: Week 4 and Week 12
The rate of surgery rate
Time frame: Week 4 and Week 12
Lund-Kennedy Scoring for Nasal Endoscopy
Time frame: Change from Baseline to Week 1, 2, 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 26992115Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.
- Background: PubMed 20451040Van Zele T, Gevaert P, Holtappels G, Beule A, Wormald PJ, Mayr S, Hens G, Hellings P, Ebbens FA, Fokkens W, Van Cauwenberge P, Bachert C. Oral steroids and doxycycline: two different approaches to treat nasal polyps. J Allergy Clin Immunol. 2010 May;125(5):1069-1076.e4. doi: 10.1016/j.jaci.2010.02.020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing steroid-eluting sinus stent implant, Systemic glucocorticoids and saline irrigations in people with Chronic Sinusitis, run by Zheng Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Liu (86 027 83663807, zhengliuent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sino-Nasal Outcome Test Scores (SNOT-22) (time frame: Change from Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.