Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT01474005
Status:
UNKNOWN
Last Update Posted:
2012-07-02
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment of an Artificial Larynx After Total Laryngectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-28', 'studyFirstSubmitDate': '2011-10-20', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the restoration of respiratory functions', 'timeFrame': 'one year', 'description': '4 items will be used:\n\n* 0: no dyspnea\n* 1: moderate dyspnea\n* 2: significant dyspnea\n* 3: major dyspnea'}, {'measure': 'Evaluation of the restoration of the ability to swallow by nasofibroscopy', 'timeFrame': 'one year', 'description': '3 items will be used:\n\n* 1: no aspiration\n* 2: moderate aspiration\n* 3: massive aspiration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laryngectomy', 'artificial larynx', 'breathing', 'swallowing', 'upper airway'], 'conditions': ['Carcinomatous Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy\n\nExclusion Criteria:\n\n* Less than 18 years\n* Contraindications to general anesthesia\n* Any situation considered by the physician operator as an exclusion\n* Pregnant women\n* Lactating women\n* Subglottic or basi-lingual tumor extension more than 1 cm\n* Prior radiotherapy\n* Severe coagulation disorders'}, 'identificationModule': {'nctId': 'NCT01474005', 'acronym': 'LA', 'briefTitle': 'Establishment of an Artificial Larynx After Total Laryngectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Establishment of an Artificial Larynx After Total Laryngectomy', 'orgStudyIdInfo': {'id': '4493'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PROTIP MEDICAL ( Artificial larynx prosthesis)', 'type': 'DEVICE', 'description': 'establishment of an artificial larynx prosthesis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091 Strasbourg Cedex', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian DEBRY, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Patrick HEMAR, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe SCHULTZ, PU-PH', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, 1 avenue Molière", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Christian DEBRY, PU-PH', 'role': 'CONTACT', 'email': 'christian.debry@chru-strasbourg.fr', 'phone': '03.88.12.76.45', 'phoneExt': '33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}