Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT02695602
Status:
TERMINATED
Last Update Posted:
2017-05-10
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Unable to recruit enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2016-02-04', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients', 'timeFrame': '3 years post-operative'}, {'measure': 'Measure of pain on the Visual Analog Scale', 'timeFrame': '3 years post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nasal Obstruction']}, 'descriptionModule': {'briefSummary': 'This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal obstruction in patients with inferior turbinate hypertrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy, with or without septal deviation will be eligible for the study.\n* Failed medical treatment\n* Have failed medical treatment for at least 1 month, and will be offered surgery\n* Patients having Septoplasty at the same time as their turbinate reduction surgery.\n\nExclusion Criteria:\n\n* Patients who have had previous turbinate reduction surgery will be excluded.\n* Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal tumors, or any other exam finding that would explain their symptoms of nasal obstruction other than enlarged inferior turbinates with or without septal deviation will be excluded.\n* Patients who are diagnosed with purely bony inferior turbinate hypertrophy as discussed below.\n* Patients on hormone or anticoagulation therapy and those who have a history of head and neck radiation therapy will be excluded.\n* All study candidates will be assessed for external nasal valve collapse via the modified Cottle maneuver, and will be excluded if they exhibit significant external or internal nasal valve collapse as their primary cause of their nasal obstruction.\n* All patients will complete the Visual Analog Scale (VAS) on nasal obstruction before and after decongestion at their preoperative visit. Patients that fail to report a score less than 5 after decongestion are likely to have bony rather than soft tissue hypertrophy. In these patients MAIT is unlikely to be an adequate surgical option, and they would derive a greater amount of benefit from SMR. Therefore these patients will be excluded from the study, and offered only SMR.'}, 'identificationModule': {'nctId': 'NCT02695602', 'briefTitle': 'Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)', 'orgStudyIdInfo': {'id': '15-01264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microdebrider-Assisted Inferior Turbinoplasty (MAIT)', 'description': 'Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz)', 'interventionNames': ['Procedure: Microdebrider-Assisted Inferior Turbinoplasty (MAIT)']}, {'type': 'EXPERIMENTAL', 'label': 'Submucous Resection (SMR)', 'description': 'Turbinoplasty using non-powered instruments', 'interventionNames': ['Procedure: Submucous Resection with non powered instrument']}], 'interventions': [{'name': 'Microdebrider-Assisted Inferior Turbinoplasty (MAIT)', 'type': 'PROCEDURE', 'otherNames': ['Medtronic'], 'armGroupLabels': ['Microdebrider-Assisted Inferior Turbinoplasty (MAIT)']}, {'name': 'Submucous Resection with non powered instrument', 'type': 'PROCEDURE', 'otherNames': ['Jansen-Middleton or straight through cut'], 'armGroupLabels': ['Submucous Resection (SMR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Seth Lieberman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}