Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 12:12 PM
Study NCT ID:
NCT00832403
Status:
SUSPENDED
Last Update Posted:
2009-01-30
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gore Tex Implants in the Treatment of Atrophic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012222', 'term': 'Rhinitis, Atrophic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'lack of new patients', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of fetid crusts and atrophy of the mucous bone covering', 'timeFrame': 'after surgery recovery'}], 'secondaryOutcomes': [{'measure': 'lack of side effects such as infection', 'timeFrame': 'after the treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrophic rhinitis', 'implants', 'Polytetrafluoroethylene'], 'conditions': ['Atrophic Rhinitis']}, 'descriptionModule': {'briefSummary': "This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa.\n\nThe Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment.\n\nAll patients have improved after the procedure.", 'detailedDescription': 'Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that were submit to surgery to treat atrophic rhinitis with implants in the nasal fossa.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of atrophic rhinitis, with previous clinical treatment without good results\n\nExclusion Criteria:\n\n* Patients with mental illness'}, 'identificationModule': {'nctId': 'NCT00832403', 'acronym': 'RA', 'briefTitle': 'Gore Tex Implants in the Treatment of Atrophic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Felicio Rocho'}, 'officialTitle': 'Gore Tex Implants in the Treatment of Atrophic Rhinitis', 'orgStudyIdInfo': {'id': 'Rinite Atrófica cep/hfr'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'polytetrafluoroethylene', 'interventionNames': ['Other: implants of polytetrafluoroethylene in tha nasal fossa']}], 'interventions': [{'name': 'implants of polytetrafluoroethylene in tha nasal fossa', 'type': 'OTHER', 'description': 'surgical implants of polytetrafluoroethylene in the nasal fossa', 'armGroupLabels': ['polytetrafluoroethylene']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Felicio Rocho', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Larissa Oliveira Lauriano', 'oldOrganization': 'Hospital Felício Rocho'}}}}