As part of Ohio Sinus Institute’s mission to incorporate the latest treatment options for our patients we frequently participate in or initiate institutional review board approved research protocols. This allows us to keep abreast of current clinical trends while also contributing new ideas for surgical and medical management of chronic rhinosinusitis. Some of Dr. Karanfilov’s studies are listed below.
Active Medical Management Protocols
1. A Clinical Evaluation of PROPEL Contour Placement Following In-Office Frontal Sinus Balloon Dilation (EXPAND STUDY)
Dr. Karanfilov is the principal investigator in this study. A post-market, randomized, intra-patient controlled, blinded, multicenter trial which is being conducted to evaluate how well the PROPEL Contour Sinus Implant works to keep the sinus open when it is placed in the frontal sinus after a successful balloon dilation procedure in both frontal sinuses is performed.
2. Point-Of-Care Qualitative Immoassay for the Detection of Bacterial Sinusitis
A new test, Sinu-Test is used to determine the accuracy in identifying sinus infections caused by at least 1 of 3 bacteria which cause most bacterial sinus infections . The study involved completing a few simple nasal questionnaires and completing a nasal swab test. This study is open and will be enrolling individuals in the fall of 2021.
3. A Clinical Trial Evaluating Treatment Responses of Dupilumab versus Omalizumab in Type 2 patients (EVEREST STUDY)
A randomized, double-blind, head-to-head comparison of dupilumab versus omalizumab in severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and comorbid asthma patients.
Completed Medical Management Protocols
1. Comparison of Balloon Sinus Dilation (Balloon Sinuplasty) for medically refractory chronic rhinosinusitis versus Maximal Medical Therapy for Chronic Rhinosinusitis.
Patients with diagnosed chronic rhinosinusitis had the option of managing their disease with a balloon sinus dilation intervention versus the second option of undergoing further medical therapy. Dr. Karanfilov served as a co-principal investigator with Dr. Chris Melroy and Dr. Spencer Payne. This study is closed.
2. A novel irrigation protocol.
A new irrigation device and irrigation formula was tested. Participants received the device and materials at no cost. This study is closed.
3. A Clinical Evaluation of the Intersect ENT Drug-coated Sinus Dilation Device I Patients with Chronic Rhinosinusitis (ASCEND STUDY)
Dr. Karanfilov served as principal investigator in this study. A randomized, intra-patient controlled, double-blinded cohort of 70 subjects to assess the safety and efficacy of the Sinus Dilation Device used for in-office dilation of frontal sinus ostia (FSO). This study is closed
4. Phase 2, Double-Blind, placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANBO20) in Adult Subjects with Chronic Rhinosinusiti with Nasal Polyposis (Eclipse Study)
Dr. Karanfilov served as an investigator on this study. Patients were double-blinded to test the safety and effectiveness of the study drug, etokimab. This study is closed.