Advanced ENT Louisville, Central KY, and Southern Indiana

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Serving Louisville, Central Kentucky and Southern Indiana.

Advanced Clinical ENT Research of Kentucky and Southern Indiana

Our Research Center was developed at our Dupont office in 2002 with a core group of seven physicians.   We have now grown to include our Popular Level office and ten physicians that participate in Clinical Research.  We are excited to offer our patients and referring physicians an opportunity to participating in cutting edge medical products and services for the diagnosis and management of otic, nasal and sinus disorders.


Ongoing Research Studies

Are Nasal Polyps Draining You?

If you're looking for a new way to manage your symptoms and take back control from nasal polyps, the Liberty Nasal Polyp Study may be able to help.

We invite individuals ages 18 and older who have bilateral nasal polyps to see if they may qualify to take part in a clinical research study.

Learn more about the Liberty Nasal Polyp Study www.NasalPolypStudy.com

Do you feel the room spinning around you? Are you sometimes dizzy? Do you have ringing in your ears, nausea, or hearing problems?

If you or someone you know has Ménière’s disease, you may qualify for a clinical study to evaluate an investigational drug that may reduce the symptoms you experience.
www.otonomyresearch.com

Concerned about a sudden change in your hearing?

Is the hearing in one of your ears suddenly seems muffled or greatly reduced, consider this research study of an investigational treatment for sudden hearing loss?

Who is eligible to participate in the ASSENT study?

To pre-qualify for this study, you must:

  • Be 18 years of age or older
  • Have had sudden hearing loss within 72 hours of beginning the study treatment
  • Not have had hearing loss from noise, air pressure change, or head trauma

All study-related visits, tests, and study medication will be provided at no cost. In addition, reimbursement for study-related time and travel may be provided. Please contact our Research Center at 502-893-0159 x1184 or 1185 for more information.

Oral Mucositis Clinical Trail

There is currently NO FDA-approved drug or biologic medication for chemoradiation-induced oral mucositis in patients with Head and Neck Cancer. Oral mucositis is the MOST COMMONLY reported side effect and is the highest reported toxicity leading to radiation treatment breaks in patients receiving chemoradiation for head and neck cancer.

Cellceutix is conducting:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Brilacidin, an Investigational Treatment for Oral Mucositis Please contact our Research Center at 502-893-0159 x1184 or 1185 for more information.


Achievements

  • Met or exceeded enrollment goals in greater than 50 trials for SAR/PAR, acute/chronic sinusitis, AOMT, AOE, tinnitus, & radiation effects.
  • Top enroller nationally in a post surgical chronic sinusitis trial
  • Top enroller nationally in trials for acute otitis media with otorrhea through tympanostomy tubes
  • Top enroller nationally in a trial for acute otitis externa
  • Top enroller for a surgical device in chronic sinusitis studies
  • 2nd highest enroller in a national trial for xerostomia
  • 2nd highest enroller in a national trial for mucositis prevention during radiation therapy
  • 2nd highest enroller in a chronic sinusitis PK surgical study
  • 2nd highest enroller in a surgical device for chronic sinusitis study
  • Top 5 enroller in a national acute bacterial sinusitis trial
  • Co-Lead Principle Investigator for a national sinus stent study
  • Lead authorship on several journal articles
  • Co-authorship on numerous journal articles

Research Mission

To conduct clinical trials in accordance with the Code of Federal Regulations and our Standard Operating Procedures with respect to Good Clinical Practice. Research is conducted in a high quality, efficient, and ethical manner to assist in the advancement of medical knowledge in our field.


Clinical Research Staff

Kathleen Sheeley, RRT, CCRC - ksheeley@advancedentandallergy.com
Jennifer Leonard, MA, CCRC - jleonard@advancedentandallergy.com
Sarah Carroll, BSN, RN, CRC - scarroll@advancedentandallergy.com


Research Experience

We, at Advanced ENT and Allergy Center, are dedicated to clinical research. We have three full time research coordinators: Kathleen Sheeley, RRT, CCRC, our Research Manager, has 16 years experience, Jennifer Leonard, MA, CCRC has 13 years experience, and Sarah Carroll, BSN, RN, CRC that tends to our research department.

Our physicians and clinical research coordinators have completed GCP training courses on the Protection of Human Subjects and our Clinical Research Coordinators have also completed training for the Transportation of Dangerous Goods. We have experience in Adult and Pediatric Phase I-IV clinical trials for the following indications; acute sinusitis, seasonal allergic rhinitis, nasal polyposis, xerostomia, mucositis, acute otitis media, recurrent otitis media, AOMT, AOE, chronic sinusitis, perennial allergic rhinitis, tinnitus, meniere’s disease, device studies, pharmaceutical studies, PK studies and outcomes studies.

Other Support Services include:

  • Three full-time Clinical Research Coordinators; two whom are CCRC certified
  • Allergy Department onsite
  • Audiology Department onsite
  • We are part of the AAO-HNS CHEER network
  • Computerized patient database of 500,000 patients
  • CT scanner onsite
  • Nine offices servicing Kentuckiana (seven in KY, two in IN)
  • Locked drug storage and locked refrigeration
  • EDC experience
  • Calibrated equipment
  • Centrifuge
  • EKG machine
  • PFT (Pulmonary Function Testing)
  • Rapid contract and regulatory document turnaround
  • Use central IRB's
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