Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06198894
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2023-12-27', 'studyFirstSubmitQcDate': '2023-12-27', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sino-Nasal Outcome Test Scores (SNOT-22)', 'timeFrame': 'Change from Baseline to Week 4', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Sino-Nasal Outcome Test Scores (SNOT-22)', 'timeFrame': 'Change from Baseline to Week 1, 2, 8, 12', 'description': '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.'}, {'measure': 'Change in nasal symptoms', 'timeFrame': 'Change from Baseline to Week 1, 2, 4, 8, 12', 'description': '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).'}, {'measure': 'Rescue medication use', 'timeFrame': 'Week 4 and Week 12', 'description': '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.'}, {'measure': 'The rate of surgery rate', 'timeFrame': 'Week 4 and Week 12', 'description': 'The rate of nasal endoscopic surgery for the experimental or control group throughout the study period will be recorded.'}, {'measure': 'Lund-Kennedy Scoring for Nasal Endoscopy', 'timeFrame': 'Change from Baseline to Week 1, 2, 4', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['steroid-eluting sinus stent', 'mucous edema'], 'conditions': ['Chronic Sinusitis']}, 'referencesModule': {'references': [{'pmid': '26992115', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20451040', 'type': 'BACKGROUND', 'citation': 'Van 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.'}]}, 'descriptionModule': {'briefSummary': 'Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n* Edema score of bilateral nasal endoscopy was 2 points both;\n* Understands the purpose and procedures of the trial and voluntarily signs the informed consent form;\n* The female subjects had no pregnancy or lactation plans during the treatment and follow-up period;\n* 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;\n* Subjects were 18-65 years old, male or non-pregnant women;\n\nExclusion Criteria:\n\n* Grade 2 or more nasal polyp scores in either nasal cavity (i.e., polyps extending beyond the middle nasal passage)\n* 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);\n* Subjects had cystic fibrosis, congenital ciliary dyskinesia, fungal globular sinusitis, systemic vasculitis and granulomatous diseases, tumors, and immune deficiency.\n* The patient underwent endoscopic nasal surgery within 3 months.\n* Acute exacerbation of allergic rhinitis, acute exacerbation of CRS, upper respiratory tract infection, or common cold in the 4 weeks prior to screening visit;\n* 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;\n* 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,'}, 'identificationModule': {'nctId': 'NCT06198894', 'briefTitle': 'Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms', 'orgStudyIdInfo': {'id': 'Stent-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steroid-eluting Sinus Implant', 'description': 'In-office bilateral placement of the sinus stent; Systemic glucocorticoid placebo; saline irrigations (250ml) twice daily', 'interventionNames': ['Procedure: steroid-eluting sinus stent implant', 'Drug: saline irrigations', 'Drug: Placebo']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'In-office bilateral sham procedure; Systemic glucocorticoid; saline irrigations (250ml) twice daily', 'interventionNames': ['Drug: Systemic glucocorticoids', 'Drug: saline irrigations', 'Procedure: sham procedure']}], 'interventions': [{'name': 'steroid-eluting sinus stent implant', 'type': 'PROCEDURE', 'otherNames': ['BISORB bioabsorbable steroid-eluting sinus stent'], 'description': 'In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia', 'armGroupLabels': ['Steroid-eluting Sinus Implant']}, {'name': 'Systemic glucocorticoids', 'type': 'DRUG', 'otherNames': ['Medrol'], 'description': '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),', 'armGroupLabels': ['Control']}, {'name': 'saline irrigations', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride solution'], 'description': 'Patients were routinely treated with saline irrigations (250ml) twice daily', 'armGroupLabels': ['Control', 'Steroid-eluting Sinus Implant']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Systemic glucocorticoid placebo'], 'description': 'Groups were given systemic glucocorticoid placebo', 'armGroupLabels': ['Steroid-eluting Sinus Implant']}, {'name': 'sham procedure', 'type': 'PROCEDURE', 'otherNames': ['In-office bilateral sham procedure of stent placement'], 'description': 'The sham procedure was performed in-office under local anesthesia', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Liu, doctor', 'role': 'CONTACT', 'email': 'zhengliuent@hotmail.com', 'phone': '86 027 83663807'}, {'name': 'Wang, Doctor', 'role': 'CONTACT'}, {'name': 'Zheng Liu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Heng Wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zheng Liu', 'role': 'CONTACT', 'email': 'zhengliuent@hotmail.com', 'phone': '86 027 83663807'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zheng Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology-Head & Neck Surgery; Deputy Dean of Tongji Medical College; Deputy Dean of Tongji Hospital of Tongji Medical College', 'investigatorFullName': 'Zheng Liu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}