Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-27 @ 11:05 AM
Study NCT ID:
NCT01695967
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'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': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '# of participants with improved nasal obstruction score from baseline to 6 months', 'timeFrame': 'baseline and 6 months', 'description': 'Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nasal obstruction'], 'conditions': ['Sleep Apnea', 'Nasal Obstruction']}, 'descriptionModule': {'briefSummary': 'patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.', 'detailedDescription': 'To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 3-16\n* obstructive sleep apnea warranting adenotonsillectomy\n* history of daytime nasal obstruction and or mouth breathing\n* failed medical treatment with either oral anti-histamine or nasal steroid spray.\n* turbinate hypertrophy on Physical Exam defined by \\>50% obstruction\n\nExclusion Criteria:\n\n* \\<3 or \\>16\n* unwillingness to comply with study procedures\n* congenital head and neck malformations, genetic syndromes, craniofacial anomalies\n* no evidence of turbinate hypertrophy or symptoms of nasal obstruction\n* pregnancy or breastfeeding\n* bleeding disorders\n* current therapy with coumadin or Pradaxa'}, 'identificationModule': {'nctId': 'NCT01695967', 'briefTitle': 'Turbinate Cauterization in Pediatric Patients With Nasal Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial', 'orgStudyIdInfo': {'id': 'version 3 03Mar2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Turbinate Cauterization', 'description': 'Turbinate Cauterization will be completed.', 'interventionNames': ['Procedure: turbinate cauterization']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no turbinate cauterization'}], 'interventions': [{'name': 'turbinate cauterization', 'type': 'PROCEDURE', 'armGroupLabels': ['Turbinate Cauterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': "Children's Hospital of the King's Daughters", 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Christina Baldassari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Virginia Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Pediatric Otolaryngology', 'investigatorFullName': 'Cristina Baldassari M.D.', 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}