Clinical trial Research

ENT expands research efforts with new clinical trials

The Department of Otolayrngology is one of the top five recipients of National Institutes of Health funding for otolaryngology research in the U.S., making it one of the leaders in the field.

The department currently has 176 open research projects, according to Sara Kukuljan, manager of the division of clinical research. These include:

  • clinical and non-clinical research studies
  • secondary studies using existing tissue specimens or data collected without patient identifiers
  • studies using health data that is publicly available

Clinical trials are often considered the pinnacle of clinical research. A clinical trial is a research study involving human participants assigned, often randomly, to a specific intervention. The study is designed to evaluate the effect(s) of the intervention on the participant; the effect being evaluated is a health-related biomedical or behavioral outcome.

“The volume and quality of research being conducted in our department is a real source of pride for all of us. Our efforts are helping to advance the field of otolaryngology while improving patient care now and into the future.”

Craig Buchman, MD, chair and Lindburg Professor of Otolaryngology

Within the last six months, the Institutional Review Board has approved a number of clinical trials where our faculty serve as principle investigator. They include:

Jill Firszt, PhD

Title: Evaluation of AutoSense OS on a Naída CI M90 Sound Processor Programmed with Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

Principle Investigator: Jill Firszt, PhD
Description: The overall goal of this clinical trial is to demonstrate the safety and efficacy of AutoSense on a M90 processor in users of the HiResolution Bionic Ear System.

Jacques Herzog, MD

Title: Cochlear Implantation in Children with Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Principle Investigator: Jill Firszt, PhD
Description: The study is a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with AHL or SSD.

Title: A post-market interventional, cohort study evaluating the clinical efficacy of the Osia 2 system in the US Market
Principle Investigator: Jacques Herzog, MD
Description: A post-market interventional cohort study evaluating the clinical efficacy of the Osia 2 system in the US Market.

headshot of David Leonard, MB, BCh, BAO
David Leonard, MB, BCh, BAO

Title: Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients
Principle Investigator: David Leonard, MB, BCh, BAO
Description: This is a single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population.

Headshot of Jonathan McJunkin
Jonathan McJunkin, MD

Title: Utilization of a Smartphone Application as a Hearing Screening Tool for Telemedicine
Principle Investigator: Jonathan McJunkin, MD
Description: The purpose of the study is to determine the accuracy of a smartphone application as a screening test for hearing loss.

Randal Paniello, MD, PhD

Title: An open-label multi-center study of INO-3107 with electroporation (EP) in subjects with HPV-6- and/or HPV-11-associated recurrent respiratory papillomatosis (RRP)
Principle Investigator: Randal Paniello, MD
Description: This is a Phase 1/2 open-label, multicenter trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects with recurrent respiratory papillomatosis (RRP).