Sponsored Clinical Trials

A randomized, double blind, placebo-controlled, multi-center study of the efficacy and safety of STG320 sublingual tablets of house dust mite (HDM) allergen extracts in adults and adolescents with HDM-associated allergic rhinitis

  • Christine Franzese, MD - Site PI
  • Sponsored by Stallergens, this clinical trial will looks at the safety and effectiveness of 12 months of treatment with STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.

Implantation of the HiRes90K™ Advantage Cochlear Implant with HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults with Partial Deafness

  • Arnaldo L. Rivera, MD - Site PI
  • Sponsored by Advanced Bionics, LLC, the primary purpose of this study is to allow Advanced Bionics to complete the development of its' electro-acoustic stimulation technology. The primary study objective is to implant and fit patients with considerable low-frequency acoustic hearing profiles (partial deafness) with the Bionic Ear System (HiRes 90K[TM] Advantage cochlear implant with HiFocus[TM] Mid-Scala electrode and prototype Advanced Bionics EAS Cochlear Implant Sound Processor).

A prospective, randomized, double blind, placebo-controlled, multicenter, phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere's disease

  • Arnaldo L. Rivera, MD - Site PI
  • Sponsored by Otonomy, Inc, this phase 3 clinical trial will aim To confirm the efficacy of OTO-104 in subjects with Meniere’s disease, as measured by the number of definitive vertigo days (DVD) at Week 12 (the 4-week interval from Week 9 through Week 12).

A 6-month, multicenter, phase 3, open-label extension safety study of OTO-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere’s disease

  • Arnaldo L. Rivera, MD - Site PI
  • Sponsored by Otonomy, Inc., the objective of this open label study is to assess the safety of repeat IT injections of 12 mg OTO-104 at 3-month intervals.

Palatal Device Providing In-situ Sensory Feedback in Patients with Vestibular Imbalance

  • Arnaldo L. Rivera, MD - Site PI
  • Sponsored by InnervoTechnology, Inc., the primary goal of the study is to determine how alternative sensory feedback on the roof of the mouth can be used to improve balance and gait for patients with vestibular loss, and reduce the risk of falling.

Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)

  • Arnaldo L. Rivera, MD - Site PI
  • Sponsored by Auris Medical, Inc., the primary objective of this clinical trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss.

PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Natural History Registry for Patients with Chronic Hypoparathyroidism

  • Robert P. Zitsch, III, MD - Site PI
  • Sponsored by Shire, this clinical trial will characterize the natural history of chronic hypoparathyroidism, including such items as its treatment, clinical outcomes, comorbidity, and mortality in patients, under conditions of normal clinical practice, regardless of disease etiology and management.

Department supported research studies

Variability in analysis of nasal projection using three different methods compared to the general population

  • C.W. David Chang, MD
  • Multiple methods for assessing nasal projection (how far the nose sticks out from the face) exist. This study will assess which, if any, method best approximates what the general population agrees is the ideal nasal projection based on unbiased opinion (i.e. no previous knowledge of facial plastics).

Cost-effectiveness and predicators of the necessity of routine culture in surgically drained peritonsillar abscesses

  • C.W. David Chang, MD, Benjamin F. Erhardt, MD
  • The goal of this study is to retrospectively review cases of surgically drained peritonsillar abscesses to determine if (a) there are any predictive demographic, clinical, or imaging factors associated with resistant organisms and/or treatment change based off culture, and (b) to assess the cost effectiveness of routine culture of surgically drained peritonsillar abscesses.

Outcomes following implementation of post-operative calcium monitoring algorithm for total & completion thyroidectomy procedures

  • C.W. David Chang, MD, Tabitha L. Galloway, MD
  • Retrospective review that aims to demonstrate improvement in patient outcomes with the use of an algorithm for post-operative calcium management in patients who underwent total and completion thyroidectomies.

Visual Temporal Bone Surgery: Defining & Translating Standardized Metrics to an Automated Assessment Tool

  • C.W. David Chang, MD
  • In collaboration with Ohio State University, this study will work to develop an integrated metrics to provide the basis for both a standardized training platform as well as a validated objective assessment of technical skills performance.

Otolaryngology residency surgical training opportunities for tracheostomy, thyroidectomy & parathyroidectomy

  • C.W. David Chang, MD, Ceisha Ukatu, MD
  • The purpose of this study is to document trends in the number of tracheostomy, thyroidectomy, and parathyroidectomy procedures being performed by otolaryngology and other surgical and interventional residents at the University of Missouri. Additionally we will compare these number to national aggregate data for the last 10 years.

Factors in Readmission to the Otolaryngology Service

  • C.W. David Chang, MD, Tiffany Baugh, MD
  • This is a retrospective chart review that aims to determine factors that make patients at high risk for readmission and will evaluate for any system/discharge process related problems that may contribute to readmission.

Use of Corticosteroids in Deep Neck Space Infections

  • C.W. David Chang, MD, Tiffany Baugh, MD
  • This is a retrospective chart review that will evaluate the frequency and type of corticosteroid used in deep neck space infections, as well as compare the use of corticosteroids in patients with different comorbidities and determine if the use of corticosteroids changed the length of stay, progression to surgical intervention, and/or airway management.

Analysis of Unmatched Otolaryngology Residency Applicants: Outcomes & Pathways after the Match

  • C.W. David Chang, MD
  • The objective for this study is to determine which activities during the intervening period of unmatched applicants reapplying for Otolaryngology are most effective in future match success in Otolaryngology. Our hypothesis is that the success in reapplication into Otolaryngology does not actually differ between pursuing a surgical internship year versus research fellowship year.

Cost analysis of the use of intraoperative frozen section evaluation for papillary and follicular thyroid lesions

  • Laura Dooley, MD, Craig Bollig, MD
  • This project will provide insight into the cost-effectiveness of the use of frozen sections to guide the surgical management of papillary and follicular lesions in light of the new ATA guidelines. The results of this study may support the use of frozen sections in this context, or provide further evidence that frozen section rarely changes surgical management and is not cost effective. Ultimately, this may lead to reduction in the utilization of health care resources. Our hypothesis is that utilization of frozen sections for follicular lesions are less cost effective than performing a completion thyroidectomy when indicated based on the new 2015 ATA guidelines.

Survey of Thyroid Surgeons on their Utilization of Intraoperative Frozen Section Analysis

  • Laura Dooley, MD, Craig Bollig, MD
  • As a follow-up to the above study, this study will survey thyroid surgeons in the United States on the use of intraoperative frozen section for papillary and follicular lesions in their practices. This project will provide information on current trends of the use of frozen sections in the United States by thyroid surgeons in light of the new ATA guidelines. Our hypothesis is that there is still a significant percentage of thyroid surgeons that use FS to evaluate follicular lesions and guide surgical management despite multiple papers discouraging its widespread use.

The Impact of PET/CT on the staging and treatment of advance head and neck squamous cell carcinoma

  • Jeffrey B. Jorgensen, MD
  • A multi-institutional, prospective, blinded, randomized clinical trial, in collaboration with the Midwest Head and Neck Cancer Consortium, that will seek to provide evidence that obtaining a PET/CT will aid in the accurate staging of advanced HNSCC, but will have no impact on the treatment plan for the disease.

The effect of intraoperative Hetastarch administration on microvascular anastomotic venous thrombosis

  • Jeffrey B. Jorgensen, MD, Tabitha L.I. Galloway, MD
  • This is a retrospective examination of free tissue transfer patients at the University of Missouri operated on by the Department of Otolaryngology January 1, 2009 through May 1, 2013 and investigate if administration of Hetastarch intraoperatively was associated with a decreased risk of venous thrombosis postoperatively.

A comparison of local complication rates for post-irradiated patients undergoing laryngectomy with free tissue transfer versus those undergoing laryngectomy with primary closure

  • Jeffrey B. Jorgensen, MD
  • This is a retrospective review to evaluate the incidence of would complications, such as fistula formation, flap necrosis, wound infection, etc. compared between two groups: patients undergoing laryngectomy with free tissue transfer vs patients undergoing laryngectomy with primary closure.

Survival Analysis of Patients with Metastatic Head and Neck Squamous Cell Carcinoma grouped by Site of Metastasis

  • Jeffrey B. Jorgensen, MD, Craig Bollig, MD
  • Retrospective analysis that will analyze survival of patients with Head and Neck Squamous cell carcinoma based on site(s) of metastatic disease, compare survival of patients who received therapy after diagnosis of metastases to those that did not pursue further treatment and delineate terminal pathways for patients with Head and Neck Cancer based on site of metastatic or advanced local disease.

Effect of perioperative hyperglycemia on the complication rate of patients undergoing microvascular free tissue transfer for head and neck reconstruction

  • Jeffrey B. Jorgensen, MD, Craig Bollig, MD
  • This a retrospective review of patients undergoing microvascular free tissue transfer for head and neck reconstruction in which preoperative glucose value, as well as the glucose level on post-operative day 1 and post-operative day 4, will be evaluated to determine if a more aggressive glucose management in patients with patients with perioperative will lead to fewer complications and reduced hospital or ICU stay, with subsequent reduction in the utilization of health care resources.

Concordance of histopathology and cytopathology of thyroid nodules at the University of Missouri

  • Jeffrey B. Jorgensen, MD
  • This study will perform an internal inspection of the histopathologic and cytopathologic results of thyroid nodules at the University of Missouri over the last 3 years, and compare it to national norms. If patients also obtained molecular testing, the results will be evaluated to see if there is concordance to national data. The aim is to better understand cytopathologic results at the University of Missouri, in order to improve medical decision making regarding risk of malignancy based on FNA results.

Predicting utility of sestamibi scans in localization of parathyroid adenomas

  • Dana M. King, MD, Jeffrey B. Jorgensen, MD, Robert P. Zitsch, III, MD
  • This project aims to a) Correlate positive sestamibi scans with biochemical markers of hyperparathyroidism, eg, calcium and PTH b) Compare radiologists' reading of sestamibi scans with surgeon's analysis of sestamibi scan readings and assess accuracy based on location of parathyroid found surgically and c) Determine if there is a biochemical cut-off below which a sestamibi scan should not be ordered based on a cost-benefit analysis.

Noninvasive clinical tools to aid early detection and monitoring of dysphagia in ALS: translating findings from mice to humans

  • Teresa E. Lever, PhD
  • Objective clinical tools are needed to reliably detect and monitor dysphagia, without extensive use of technology or radiation exposure. We propose that measures of tongue and jaw rates of movement similar to those used in our ALS mouse research may be robust clinical tools for this purpose. Additionally, these objective clinical tools will be highly useful for measuring the effectiveness of novel pharmaceutical treatments for dysphagia in ALS.

Characterization of the laryngeal adductor reflex in humans using flexible endoscopic evaluation of swallowing with sensory testing

  • Teresa E. Lever, PhD, Bridget L. Hopewell, MD
  • This prospective study seeks to provide evidence that Flexible Endoscopic Evaluation of Swallowing with Sensory Testing (FEESST) may be able to generate more valuable data to detect more subtle pathology than it has previously been used for. We will use the endoscope and capture the same video feed that is typically used in clinical practice, however we will analyze the video in a different manner. It can then be used to follow treatment outcomes of interventions for patients with dysphagia.

Thickening fluids for pediatric patients with dysphagia: the challenges of achieving and maintaining safe viscosities

  • Teresa E. Lever, MD
  • The study will aim to answer the following questions: Does baby formula thicken to different viscosities when thickening agents are added, based on the caloric density of the original (unthickened) formula? How quickly and to what degree does thickened breast milk decrease in viscosity? The purpose of the study is to enhance feeding safety and quality of patient care for infants and children with feeding and swallowing deficits.

A double-blind, placebo-controlled, randomized trial of pentoxifylline for imbalance secondary to insufficient microvascular perfusion

  • Arnaldo L. Rivera, MD, Michael D. Puricelli, MD
  • The aim of this prospective study is to determine if pentoxifylline, which increases perfusion at the microvascular level, improves quality of life, symptom severity, and functionality among patients with imbalance, dizziness, and vertigo secondary to microvascular insufficiency. Analysis of this data will permit determination of the appropriateness of pentoxifylline use among specific diagnostic groups and create the expertise and infrastructure for future trials among other medications and modalities for imbalance.

Review of the Management of Facial Nerve Paralysis at University of Missouri Hospital and Clinics

  • Arnaldo L. Rivera, MD, Ceisha Ukatu MD
  • The patients who present for treatment of facial nerve paralysis at MU are seen by a variety of different physicians in different departments. Given this fact, it is unclear whether all patients are receiving similar workup and management of their disease process. Gathering retrospective data on patients treated at MU for facial nerve paralysis will allow us to determine if patients are receiving recommended care. The ultimate intended purpose is to decrease harmful variations in the evaluation and management of facial nerve paralysis at our institution. The results will also give valuable information in the preparation for a prospective trial on the treatment of these patients.

Hearing Results and Post-Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial

  • Arnaldo L. Rivera, MD, Christopher E. Kennel, MD
  • This study seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

Changes in tumor size and margins after resection and fixation of oral cavity cancer specimens

  • Robert P. Zitsch, MD, Gregory Renner, MD
  • The purpose of this prospective study is to quantify the degree of shrinkage of tumor dimension & tumor-free margins after resection and formalin fixation of oral cavity squamous cell carcinoma specimens.

The effect of pre-operative administration of vitamin D levels on post-thyroidectomy hypocalcemia

  • Robert P. Zitsch, MD
  • This dual retrospective and prospective study seeks to provide evidence that a simple change in pre-operative patient management can lead to better patient outcomes and shorter hospital stays.

Cholesteotoma recidivism following canal wall up versus canal wall down technique of mastoidectomy

  • Robert P. Zitsch, MD, Michael D. Puricelli, MD
  • This study will retrospectively review mastoidectomy cases at University of Missouri Healthcare to document the site of initial disease and rate of recidivism to provide insight into the issue of whether a second stage surgery may be avoided and immediate reconstruction completed in selected cases. In addition, we plan to contribute recent data regarding the rate of recidivism CWU and CWD mastoidectomy.

Optimal Hydrochlorothiazide cessation widow in diagnosis of primary hyperparathyroidism

  • Robert P. Zitsch, MD, Michael D. Puricelli, MD
  • This study aims to serially measure serologic and urologic data obtained under strictly controlled calcium and vitamin D intake conditions before and after participants discontinue the use of hydrochlorothiazide when undergoing diagnostic evaluation for primary hyperparathyroidism. Analysis of this data will permit reconciliation of current conflicting recommendations for how long the medication must be held prior to performance of testing to calculate the calcium/creatinine clearance ratio and facilitate determination of the optimal hydrochlorothiazide cessation window for the diagnosis of primary hyperparathyroidism.