Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT06275269
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2024-02-17', 'studyFirstSubmitQcDate': '2024-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Short-Term Postoperative Complications', 'timeFrame': 'one week after intervention', 'description': 'Follow-up on short-term postoperative complications (including pneumothorax, bleeding, wound infection, pain, fever, etc.)'}], 'secondaryOutcomes': [{'measure': 'Overall medical expenses incurred by patients', 'timeFrame': 'one week after intervention', 'description': 'Overall medical expenses incurred'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subglottic Stenosis', 'Triamcinolone', 'Translaryngeal Endoscopic Mucosal Injection', 'Ultrasound-Guided Injection'], 'conditions': ['Subglottic Stenosis']}, 'descriptionModule': {'briefSummary': 'This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."\n* 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."\n\nExclusion Criteria:\n\n* 1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."\n* 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."\n* 3: "Pregnant or lactating women."\n* 4: "Unstable angina, congestive heart failure, severe bronchial asthma."\n* 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 \\<60mmHg after oxygen therapy or mechanical ventilation)."\n* 6: "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment."\n* 7: "Patients do not agree to participate in this study."\n* 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."\n* 9: "Researchers believe there are any circumstances making the patient unsuitable for inclusion."'}, 'identificationModule': {'nctId': 'NCT06275269', 'briefTitle': 'Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Comparison of the Safety and Economics of Translaryngeal Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone for the Treatment of Subglottic Stenosis: a Multicenter, Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'ZRJY2021-BJ08-04-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound-Guided Triamcinolone Injection Treatment Group', 'description': 'Ultrasound-Guided Triamcinolone Injection for the Treatment of Subglottic Stenosis', 'interventionNames': ['Procedure: Ultrasound-Guided']}, {'type': 'EXPERIMENTAL', 'label': 'Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group', 'description': 'Translaryngeal Endoscopic Mucosal Injection for the Treatment of Subglottic Stenosis', 'interventionNames': ['Procedure: Translaryngeal Endoscopic Mucosal Injection']}], 'interventions': [{'name': 'Ultrasound-Guided', 'type': 'PROCEDURE', 'description': 'Ultrasound-Guided Triamcinolone Injection', 'armGroupLabels': ['Ultrasound-Guided Triamcinolone Injection Treatment Group']}, {'name': 'Translaryngeal Endoscopic Mucosal Injection', 'type': 'PROCEDURE', 'description': 'Translaryngeal Endoscopic Mucosal Injection of Triamcinolone', 'armGroupLabels': ['Translaryngeal Endoscopic Mucosal Injection of Triamcinolone Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingming Deng', 'role': 'CONTACT', 'email': 'isdeng1017@163.com', 'phone': '86 18801336854'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Gang Hou, PI', 'role': 'CONTACT', 'email': 'hougangcmu@163.com', 'phone': '01084206250'}, {'name': 'Mingming Deng, Phd', 'role': 'CONTACT', 'email': 'isdeng1017@163.com', 'phone': '18801336854'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gang Hou', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}