Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-29 @ 10:39 AM
Study NCT ID:
NCT00942903
Status:
COMPLETED
Last Update Posted:
2010-10-22
First Post:
2009-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'f.hilgers@nki.nl', 'phone': '+31-20-5122550', 'title': 'Prof. Dr. F.J.M. Hilgers', 'organization': 'The Netherlands Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored during the three weeks of the study', 'description': "Adverse events were assessed during the three weeks the patients used the HME's, upon notification of a problem by the patient, and when the patient returned for a visit. When patients start using a new type of HME, they may need to adjust and may perceive an increased breathing resistance. This was not considered an adverse event.", 'eventGroups': [{'id': 'EG000', 'title': 'Provox XtraHME', 'description': 'A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Preference for Provox HME or Provox XtraHME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Provox XtraHME', 'description': 'A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks'}], 'classes': [{'title': 'Preference new Provox XtraHME', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': "Preference 'old' Provox HME", 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'No preference', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks', 'description': 'the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Noise at Stoma Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Provox XtraHME', 'description': 'A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks'}], 'classes': [{'title': 'No noise at stoma occlusion', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Noise at stoma occlusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks', 'description': 'the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Provox XtraHME', 'description': 'A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Provox XtraHME', 'description': 'A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '9.07', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-13', 'studyFirstSubmitDate': '2009-07-20', 'resultsFirstSubmitDate': '2010-08-04', 'studyFirstSubmitQcDate': '2009-07-20', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-04', 'studyFirstPostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Preference for Provox HME or Provox XtraHME', 'timeFrame': '3 weeks', 'description': 'the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.'}], 'secondaryOutcomes': [{'measure': 'Noise at Stoma Occlusion', 'timeFrame': '3 weeks', 'description': 'the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HME', 'Provox', 'voice prosthesis', 'laryngectomy'], 'conditions': ['Total Laryngectomy']}, 'descriptionModule': {'briefSummary': 'This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* total laryngectomy\n* compliant Provox HME user (24/7 use)\n\nExclusion Criteria:\n\n* current medical problems that might influence HME use'}, 'identificationModule': {'nctId': 'NCT00942903', 'acronym': 'N08HME', 'briefTitle': 'Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atos Medical AB'}, 'officialTitle': 'Phase 1 Study. Short-term Feasibility of the Next Generation Provox HMEs for Pulmonary Rehabilitation After Total Laryngectomy', 'orgStudyIdInfo': {'id': 'UD781_3CHME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compliant HME users', 'description': 'Laryngectomized patients who are currently compliant (24/7) users of a Provox HME', 'interventionNames': ['Device: Provox Xtra HME']}], 'interventions': [{'name': 'Provox Xtra HME', 'type': 'DEVICE', 'otherNames': ['Heat and Moisture Exchanger', 'Provox HME'], 'description': 'Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy', 'armGroupLabels': ['Compliant HME users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Frans JM Hilgers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atos Medical AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Corina van As-Brooks, Clinical Affairs Manager', 'oldOrganization': 'Atos Medical'}}}}