Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-04 @ 8:38 PM
Study NCT ID:
NCT02672904
Status:
UNKNOWN
Last Update Posted:
2016-10-11
First Post:
2016-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054020', 'term': 'Lasers, Gas'}, {'id': 'D053844', 'term': 'Lasers, Solid-State'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of surgery', 'timeFrame': 'intraoperative', 'description': 'total time (minutes) of surgical procedure'}, {'measure': 'number of surgical interventions', 'timeFrame': '3 years', 'description': 'total number of surgical interventions needed to eliminate the disease'}, {'measure': 'Recovery time after surgery', 'timeFrame': 'up to 3 years', 'description': 'recovery in terms of overall function, breathing, swallowing and vocal communication'}, {'measure': 'voice quality results In the short term', 'timeFrame': '6 month after last intervention', 'description': 'objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire'}, {'measure': 'voice quality results In the long term', 'timeFrame': '3 years after last intervention', 'description': 'objective measurement- voice lab analysis, and subjective measurement- Voice Handicap Index questionnaire'}, {'measure': 'Cure rates in terms of local, regional or distant recurrence events', 'timeFrame': '3 years after last intervention', 'description': 'evidence of malignant disease in the larynx, cervical lymph nodes or distant metastases'}, {'measure': 'Overall survival and disease-dependent survival over a period of at least 3 years', 'timeFrame': '3 years after last intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vocal cord', 'carcinoma', 'ktp laser', 'co2 laser', 'endoscopic surgery'], 'conditions': ['Laryngeal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '19941682', 'type': 'BACKGROUND', 'citation': 'Burns JA, Friedman AD, Lutch MJ, Hillman RE, Zeitels SM. Value and utility of 532 nanometre pulsed potassium-titanyl-phosphate laser in endoscopic laryngeal surgery. J Laryngol Otol. 2010 Apr;124(4):407-11. doi: 10.1017/S0022215109991824. Epub 2009 Nov 27.'}, {'pmid': '18710131', 'type': 'BACKGROUND', 'citation': 'Zeitels SM, Burns JA, Lopez-Guerra G, Anderson RR, Hillman RE. Photoangiolytic laser treatment of early glottic cancer: a new management strategy. Ann Otol Rhinol Laryngol Suppl. 2008 Jul;199:3-24. doi: 10.1177/00034894081170s701.'}, {'pmid': '18317789', 'type': 'BACKGROUND', 'citation': 'Lin DS, Cheng SC, Su WF. Potassium titanyl phosphate laser treatment of intubation vocal granuloma. Eur Arch Otorhinolaryngol. 2008 Oct;265(10):1233-8. doi: 10.1007/s00405-008-0628-6. Epub 2008 Mar 4.'}, {'pmid': '16944655', 'type': 'BACKGROUND', 'citation': 'Zeitels SM, Akst LM, Bums JA, Hillman RE, Broadhurst MS, Anderson RR. Pulsed angiolytic laser treatment of ectasias and varices in singers. Ann Otol Rhinol Laryngol. 2006 Aug;115(8):571-80. doi: 10.1177/000348940611500802.'}, {'pmid': '16676821', 'type': 'BACKGROUND', 'citation': 'Hirano S, Yamashita M, Kitamura M, Takagita S. Photocoagulation of microvascular and hemorrhagic lesions of the vocal fold with the KTP laser. Ann Otol Rhinol Laryngol. 2006 Apr;115(4):253-9. doi: 10.1177/000348940611500402.'}, {'pmid': '11376814', 'type': 'BACKGROUND', 'citation': 'Kacker A, April M, Ward RF. Use of potassium titanyl phosphate (KTP) laser in management of subglottic hemangiomas. Int J Pediatr Otorhinolaryngol. 2001 May 31;59(1):15-21. doi: 10.1016/s0165-5876(01)00451-7.'}, {'pmid': '17986877', 'type': 'BACKGROUND', 'citation': 'Zeitels SM, Burns JA. Office-based laryngeal laser surgery with the 532-nm pulsed-potassium-titanyl-phosphate laser. Curr Opin Otolaryngol Head Neck Surg. 2007 Dec;15(6):394-400. doi: 10.1097/MOO.0b013e3282f1fbb2.'}, {'pmid': '17044539', 'type': 'BACKGROUND', 'citation': 'Zeitels SM, Akst LM, Burns JA, Hillman RE, Broadhurst MS, Anderson RR. Office-based 532-nm pulsed KTP laser treatment of glottal papillomatosis and dysplasia. Ann Otol Rhinol Laryngol. 2006 Sep;115(9):679-85. doi: 10.1177/000348940611500905.'}]}, 'descriptionModule': {'briefSummary': 'comparison results of treatment of early stage glottic cancer between two methods of surgical treatment - CO2 laser and KTP laser', 'detailedDescription': 'Randomized controlled double-blinded study. The study group includes patients diagnosed with early glottic cancer, either carcinoma in situ or T1a-b,N0M0 squamous cell carcinoma.\n\nPatients will undergo examination and treatment and at least 3 years of follow-up.\n\n40 cancer patients will be included. The participants will be randomly divided into two groups: the first will be treated by KTP laser and the second by CO2 laser.\n\nThe patients will be blinded to the method of treatment. To enable double-blinding, the investigator performing the surgery would be the only one knowing which research group the patient belongs to. The investigator in charge of collecting the data after the operation will be blinded to the treatment method.\n\nEach participant will undergo pre-operative evaluation and follow-up after surgery in both arms.\n\nPreoperative evaluation will include:\n\n* Voice Handicap Index questionnaire\n* GRBAS - subjective assessment of voice quality.\n* Video-stroboscopy of vocal cords\n* Voice Analysis .\n\nFollow-up after surgery:\n\n* Visit 6 weeks after surgery (± two weeks), and then every three months (± 6 weeks).\n* repeated full evaluation (questionnaire, GRBAS, Stroboscopy, voice analysis) in 30 weeks of follow up and 3 years of follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pre-operative diagnosis of squamous cell cancer of the vocal cords at an early stage ( Carcinoma in situ or T1-glottic carcinoma).\n\nExclusion Criteria:\n\n* Patients who underwent previous significant vocal cords surgical intervention , or irradiation.\n* Contraindications to any endoscopic surgical treatment (general health condition, patient refusal, technical surgical difficulties)'}, 'identificationModule': {'nctId': 'NCT02672904', 'briefTitle': 'KTP vs CO2 Laser for the Treatment of Laryngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Kaplan Medical Center'}, 'officialTitle': 'Comparison Between the Use of KTP Laser vs. CO2 Laser for Endoscopic Surgical Removal of Malignant Neoplasms of the Vocal Cords', 'orgStudyIdInfo': {'id': '0057-11-KMC-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CO2 laser', 'description': 'Patients undergoing endoscopic treatment with CO2 laser', 'interventionNames': ['Device: CO2 laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KTP laser', 'description': 'Patients undergoing endoscopic treatment with KTP laser', 'interventionNames': ['Device: KTP laser']}], 'interventions': [{'name': 'CO2 laser', 'type': 'DEVICE', 'description': 'surgical removal of carcinoma from the vocal cords with CO2 laser', 'armGroupLabels': ['CO2 laser']}, {'name': 'KTP laser', 'type': 'DEVICE', 'description': 'surgical removal of carcinoma from the vocal cords with KTP laser', 'armGroupLabels': ['KTP laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rehovot', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yonatan Lahav, Dr', 'role': 'CONTACT', 'email': 'Yonatan_L@clalit.org.il', 'phone': '_972-50-7473045'}, {'name': 'Yaara Haimovich', 'role': 'CONTACT', 'email': 'yaaraha@clalit.org.il', 'phone': '+972-52-8580806'}], 'facility': 'Kapkan medical center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}], 'centralContacts': [{'name': 'Yonatan Lahav, Dr', 'role': 'CONTACT', 'email': 'Yonatan_L@clalit.org.il', 'phone': '+972-507473045'}, {'name': 'Yaara Haimovich', 'role': 'CONTACT', 'email': 'yaaraha@clalit.org.il', 'phone': '+972-528580806'}], 'overallOfficials': [{'name': 'Yonatan Lahav, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaplan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaplan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Yonatan Lahav', 'investigatorFullName': 'Dr Yonatan Lahav', 'investigatorAffiliation': 'Kaplan Medical Center'}}}}