Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis
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|ClinicalTrials.gov Identifier: NCT03083392|
Recruitment Status : Not yet recruiting
First Posted : March 20, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Maxillary Sinusitis||Procedure: treatment of chronic maxillary sinusitis using DIVA system Device: "dynamic implant valve approach" - DIVA system||Not Applicable|
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.
The 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".
The 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:
- 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.
- 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.
By appropriate advance planning, the implant, after eradication of the disease, can later be used for prosthetic purposes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis|
|Estimated Study Start Date :||March 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2019|
treatment of chronic maxillary sinusitis using DIVA system
Procedure: treatment of chronic maxillary sinusitis using DIVA system
chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage
Device: "dynamic implant valve approach" - DIVA system
The DIVA system will be used to apply saline lavage to the maxillary sinus
- resolution of chronic maxillary sinusitis [ Time Frame: three months ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083392
|Contact: Ruth Angel-Dar, Dr.||+firstname.lastname@example.org|
|Contact: Samer Srouji, Prof.||+email@example.com|
|Western Galilee Medical Center||Not yet recruiting|
|Contact: Sigal Shor +972-4-9107270 firstname.lastname@example.org|
|Study Director:||Samer Srouji, Prof.||Western Galilee Medical Center|