Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 4:53 AM
Study NCT ID:
NCT01319305
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2011-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BREATHE Long-Term Follow-Up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2011-03-14', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SNOT-20 scores', 'timeFrame': 'approximately 24 months', 'description': 'Assess post-procedure outcomes defined as SNOT-20 scores and work productivity assessment questionnaires aproximately 24 months post-procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Sinus Disease']}, 'descriptionModule': {'briefSummary': 'This is a long-term follow-up of patients that participated in the BREATHE I study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who were treated with FinESS Sinus Treatment in the BREATHE I Study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in BREATHE I study\n* Willing to sign consent and participate in long-term follow-up study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01319305', 'briefTitle': 'BREATHE Long-Term Follow-Up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entellus Medical, Inc.'}, 'officialTitle': 'BREATHE Long-Term Follow-Up Study', 'orgStudyIdInfo': {'id': '1743-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BREATHE I participatants', 'interventionNames': ['Device: FinESS Sinus Treatment']}], 'interventions': [{'name': 'FinESS Sinus Treatment', 'type': 'DEVICE', 'description': 'balloon sinuplasty', 'armGroupLabels': ['BREATHE I participatants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St. Cloud ENT', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entellus Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Robyn Schacherer, Principal CRA', 'oldOrganization': 'Entellus Medical'}}}}