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.
Research
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.
Completed Surgical Management Protocols
1. Office-Based Balloon Sinus Dilation: A prospective multi-center study of 203 patients
Dr. Karanfilov served as principal investigator for the world’s largest clinical trial to date evaluating the safety, efficacy and tolerability of balloon sinus dilation in the office setting under local anesthesia. 14 clinical sites contributed patients to the study and the results have been presented as an oral presentation at the Spring Combined Otolaryngological Society Meeting during the American Rhinologic Society Session. The manuscript for publication has been accepted into the prestigious International Forum of Allergy and Rhinology and is currently in the revision stage. A summary of the data demonstrated patency rates exceeding 90%, qualities of life measures significantly improving and radiographic scores showing statistically significant improvement. Greater than 83% of patients found the procedure tolerable and the majority of patients returned to work within 2 days. This study is closed.
2. Office-Based Image Guided Balloon Sinus Dilation: A retrospective review of cases and clinical recommendations.
We enrolled patients who were candidates for image guided surgery with the option of performing the procedure in the office. Ohio Sinus Institute has heavily invested in latest equipment including a stereotactic computer image guided machine that serves as a navigation system for the sinuses. The goal of the study was to define patient criteria for office based sinus dilation and explain the role an image guided system has in the office setting. Currently offered to nearly all patients undergoing balloon sinus dilation. This study is closed.
Completed Imaging Research
1. A prospective survey of patients undergoing point of care office based cat scanning with a cone beam cat scanner versus traditional helical cat scanning.
Patients interested is this study completed a one page survey commenting on their experience with a hospital based cat scanner versus our point of care office based scanner. This study is closed.
2. A retrospective review of the first 1000 Cone Beam Cat Scans with emphasis on abnormal findings, Lund-Makay Scoring and utilization assessment. This study is closed.
3. A retrospective review of post balloon dilation peripheral sinuses comparing presurgical dimensions to post surgical healed dimensions. This study is closed.
Information for Patients
For all patients who are interested in participating in our open protocols, please contact the office, 614-771- 9871, or email at ohiosinus@gmail.com. Dr. Karanfilov has been participating and conducting both basic science and clinical research protocols since 1990. Ohio Sinus Institute has completed the human subjects protection course guiding protocol methods through the National Institutes of Health. This insures the safety of our patients and the integrity of the research. Additionally, most protocols are monitored and approved by either local institutional review boards (OhioHealth) or national review boards (Western IRB).
Information for Industry
Ohio Sinus Institute is a private medical practice with a tertiary Rhinologic referral base. Patient volume is excellent and office capabilities are second to known. We offer in house:
- Cone Beam Cat Scanning
- Nasal Endoscopy with Digital Image Archiving
- Office Procedures:
- Balloon Sinus Dilation
- Turbinate Surgery
- Epistaxis Control
- Polyp Surgery
- Office Computer Image Guided Surgery
- EMR
- Research Coordinator
Our practice model and technological advancements allow for flexible research timelines while achieving budgetary goals.