Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT03083392
Status:
UNKNOWN
Last Update Posted:
2017-03-20
First Post:
2017-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015523', 'term': 'Maxillary Sinusitis'}, {'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2017-03-05', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resolution of chronic maxillary sinusitis', 'timeFrame': 'three months', 'description': 'After three months of follow-up, the patient will be assessed by a combination of medical tests (clinical, endoscopic and radiologic assessment), in order to determine if the maxillary sinusitis has completely resolved. The investigators expect to see complete resolution of the sinus pathological state (e.g. no evidence of sinusitis)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DIVA', 'sinusitis', 'maxillary'], 'conditions': ['Maxillary Sinusitis']}, 'referencesModule': {'references': [{'pmid': '22186252', 'type': 'BACKGROUND', 'citation': 'Albu S, Baciut M, Opincariu I, Rotaru H, Dinu C. The canine fossa puncture technique in chronic odontogenic maxillary sinusitis. Am J Rhinol Allergy. 2011 Sep-Oct;25(5):358-62. doi: 10.2500/ajra.2011.25.3673.'}, {'pmid': '22469599', 'type': 'BACKGROUND', 'citation': 'Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.'}, {'pmid': '18504152', 'type': 'BACKGROUND', 'citation': 'Ludlow JB, Ivanovic M. Comparative dosimetry of dental CBCT devices and 64-slice CT for oral and maxillofacial radiology. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jul;106(1):106-14. doi: 10.1016/j.tripleo.2008.03.018. Epub 2008 May 27.'}, {'pmid': '21050639', 'type': 'BACKGROUND', 'citation': 'Nahlieli O, Moshonov J, Zagury A, Michaeli E, Casap N. Endoscopic approach to dental implantology. J Oral Maxillofac Surg. 2011 Jan;69(1):186-91. doi: 10.1016/j.joms.2010.07.071. Epub 2010 Nov 2.'}, {'pmid': '24278950', 'type': 'BACKGROUND', 'citation': 'Nahlieli O, Casap N, Moshonov J, Zagury A, Michali E, Samuni Y. A novel dental implant system with an internal port for endoscopic closed sinus augmentation: a feasibility study in pigs. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):e556-61. doi: 10.11607/jomi.te36.'}, {'pmid': '20369083', 'type': 'BACKGROUND', 'citation': 'Neugebauer J, Ritter L, Mischkowski RA, Dreiseidler T, Scherer P, Ketterle M, Rothamel D, Zoller JE. Evaluation of maxillary sinus anatomy by cone-beam CT prior to sinus floor elevation. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):258-65.'}, {'pmid': '17761281', 'type': 'BACKGROUND', 'citation': 'Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to evaluate the efficiency of utilizing "dynamic implant valve approach" (DIVA) system in treating chronic maxillary sinusitis.', 'detailedDescription': 'A prospective study aimed to test the efficiency of a minimal interventional approach in treating chronic maxillary sinusitis. The "dynamic implant valve approach" (DIVA), a minimally invasive approach utilizes a dental implant, designed with an internal sealing screw that might serve as drug delivery system via its channel. The implant is inserted to a posterior maxillary edentulous area, creating a connection between the sinus cavity and the oral cavity (Oro-antral connection), hence, provides a controlled working channel for diagnosis and treatment of the disease (e.g; allowing drainage, lavage and sinus endoscopy). The implant is a medical device approved for use at the anatomical area of interest.\n\nThe treatment method proposed in this study is based on the principle of a conventional treatment of washing the maxillary sinus cavity called "Antral puncture and lavage".\n\nThe changes that are proposed in this study could make the operation more convenient and effective in the therapeutic level, both for the patient and the clinician for the following reasons:\n\n* DIVA (Dynamic Implant Valve Approach) Implant with a multi- useful working channel: the mere presence of the canal in the center of the implant with a screw seal, ensures controlled Oro-antral connection, and enables multiple endoscopy and lavage procedures until resolution of the pathological condition is achieved.\n* The anatomical location of the puncture / penetration to the sinus - is performed in the maxillary edentulous region. This is the lowest area of the sinus cavity (standing or sitting posture), which utilizes gravity for drainage and extraction of the contaminated contents of the sinus.\n\nBy appropriate advance planning, the implant, after eradication of the disease, can later be used for prosthetic purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No medical history of diseases involving bone metabolism\n* Unilateral or bilateral maxillary sinusitis, as evident by radiographic and endoscopic modaleties, which have not responded to optimal conservative treatment\n* Patient who is edentulous in the maxillary region and is interested in dental implant\n* The patient does not participate in another clinical study\n* The patient can read and understand the informed consent\n\nExclusion Criteria:\n\n* Medical history of increased risk of developing bone necrosis (MRONJ - medically related osteonecrosis of the jaw , or ORN - osteoradionecrosis)\n* patients who are not interested or need dental implants\n* Patients with maxillary sinus neoplastic pathology\n* Chronic maxillary sinusitis with polyps\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03083392', 'briefTitle': 'Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis', 'orgStudyIdInfo': {'id': '0015-17-NHR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'treatment of chronic maxillary sinusitis using DIVA system', 'interventionNames': ['Procedure: treatment of chronic maxillary sinusitis using DIVA system', 'Device: "dynamic implant valve approach" - DIVA system']}], 'interventions': [{'name': 'treatment of chronic maxillary sinusitis using DIVA system', 'type': 'PROCEDURE', 'description': 'chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage', 'armGroupLabels': ['Treatment']}, {'name': '"dynamic implant valve approach" - DIVA system', 'type': 'DEVICE', 'description': 'The DIVA system will be used to apply saline lavage to the maxillary sinus', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nahariya', 'country': 'Israel', 'contacts': [{'name': 'Sigal Shor', 'role': 'CONTACT', 'email': 'sigal.shor@naharia.health.gov.il', 'phone': '+972-4-9107270'}], 'facility': 'Western Galilee Medical Center', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'centralContacts': [{'name': 'Ruth Angel-Dar, Dr.', 'role': 'CONTACT', 'email': 'rutiangel123@gmail.com', 'phone': '+972-4-9107076'}, {'name': 'Samer Srouji, Prof.', 'role': 'CONTACT', 'email': 'dr.samersrouji@gmail.com', 'phone': '+972-4-9107270'}], 'overallOfficials': [{'name': 'Samer Srouji, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Western Galilee Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ruth angel dar', 'investigatorAffiliation': 'Western Galilee Hospital-Nahariya'}}}}