Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT01276418
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2011-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ENT FiberLase CO2 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054020', 'term': 'Lasers, Gas'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2011-01-09', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to complete procedure with the study device', 'timeFrame': 'Immediate - during intervention', 'description': 'The number of interventions that were completed using the AcuPulse WG and FiberLase CO2 Fiber for the intended indication, without the need to revert to other means'}, {'measure': 'Complications (bleeding, perforation, damage to non target tissue)', 'timeFrame': 'During intervention and up to 6 weeks following the procedure', 'description': 'Number of subjects with Adverse Events as a Measure of Safety'}]}, 'conditionsModule': {'conditions': ['Laryngeal Diseases', 'Pharyngeal Diseases']}, 'descriptionModule': {'briefSummary': 'This study is intended to collect data regarding treatment with a new flexible fiber used to transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study will include a single treatment that is performed transorally (through the mouth) for oral or laryngeal indications in the field of Ear, Nose and Throate (ENT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.\n2. Adult\n3. Able and willing to comply with all visit, treatment and evaluation schedule and requirements\n4. Able to understand and provide written Informed Consent\n5. Disease which requires tissue ablation for treatment\n\nExclusion Criteria:\n\n1. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);\n2. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process\n3. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;\n4. Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research"}, 'identificationModule': {'nctId': 'NCT01276418', 'briefTitle': 'ENT FiberLase CO2 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumenis Be Ltd.'}, 'officialTitle': 'ENT FiberLase CO2 Study', 'orgStudyIdInfo': {'id': 'LUM-SBUSUR-ACF-09-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Device: CO2 laser']}], 'interventions': [{'name': 'CO2 laser', 'type': 'DEVICE', 'otherNames': ['Acupulse WG CO2 Laser', 'Fiberlase Flexible Fiber'], 'description': 'Ablation and coagulation of soft tissue', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'University Hospital of Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Cesena', 'country': 'Italy', 'facility': 'Bufalini Hospital', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumenis Be Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}