DEPARTMENT OF ENT, HEAD AND NECK SURGERY
INTRODUCTION
Our department has the capability to carry out successful Phase III clinical trials. We are primarily equipped for examinations in rhinology, audiology, otology, and head and neck oncology. Our units, (allergology, and objective and subjective audiology), our large number of patients from the entire country, our excellent health specialists and our equipment park ensure that the clinical trials will be implemented successfully
Number of clinical trial investigators with Good Clinical Practice (GCP) certificate : 2
Number of clinical trial doctors with Good Clinical Practice (GCP) certificate: 7
Number of specialist doctors with Clinical Pharmacology certificate: 0
EQUIPMENT FOR CLINICAL TRIALS
- objective vestibular examinations:
- otometrics ICS impulse video oculograph for objective recording of spontaneous nystagmus, positional nystagmus, oculomotor tests and head-impulse tests
- videonystagmograph for objective recording of spontaneous nystagmus, oculomotor tests, caloric stimulation
- cVEMP
- objective audiological tests (BERA, ASSR, MLR, MFT, STR, OAE)
- stroboscope
- fiberscope
- high resolution operation microscope
- 0, 30, 70 degree nose endoscope, with video recording
- 0, 30, 45 degree ear endoscope
- navigation system for sinus and skull base surgeries
- neuromonitor
REFERENCE CLINICAL TRIALS
| Protokoll száma | Vizsgálat neve | Vizsgálatvezető neve |
1 | D5242C00001 | Multicentre, randomized, double-blind, parallel | Dr. István Szanyi |
2 | LPS16747 / EVEREST | A randomised, double-blind, head-to-head comparison of dumilumab and omalizumab in patients with severe chronic rhinosinusitis with nasal polyps (CRSWNP) and asthma comorbidities | Dr. László Lujber |
3
| EFC16723 | Randomised, double-blind, placebo-controlled, 2-part trial to evaluate the efficacy and safety of dupilumab in uncontrolled patients with chronic rhinosinusitis without nasal polyposis (CRSsNP). | Dr. László Lujber |
|
PRINCIPAL INVESTIGATIONS
Dr. habil István Szanyi PhD |
| |
POSITION | Director, University Associate Professor | |
QUALIFICATIONS | Otorhinolaryngology, Audiology, Phoniatrics | |
LICENCE VIZSGA | foniátria | |
SCIENTIFIC INTEREST | molecular examination of head and neck tumors, thyroid surgery, functional endoscopic sinus surgery, pathophysiology of chronic rhinosinusitis, use of KTP-532 laser in sinus and middle ear surgery, modern implantation methods in hearing improvement, pituitary surgery, stapes surgery, endoscopic ear surgery, head and neck oncology | |
REFERENCE TESTS | D5242C00001 Multicentre, randomized, double-blind, parallel placebo-controlled, Phase 3 clinical trial to evaluate tezepelumab and its safety in patients with rhinosinusitis with nasal polyposis (WAYPOINT). | |
| AVAILABLE FOR PERFORMING CLINICAL TRIALS | Phase 2-4 | |
Dr. habil László Lujber PhD |
| |
POSITION | University Associate Professor | |
QUALIFICATIONS | Otorhinolaryngology, Audiology | |
REFERENCE CLINICAL TRIALS | LPS16747 / EVEREST A randomised, double-blind, head-to-head comparison of dumilumab and omalizumab in patients with severe chronic rhinosinusitis with nasal polyps (CRSWNP) and asthma comorbidities. EFC16723A Randomised, double-blind, placebo-controlled, 2-part trial to evaluate the efficacy and safety of dupilumab in uncontrolled patients with chronic rhinosinusitis without nasal polyposis (CRSsNP). | |
| AVAILABLE FOR PERFORMING CLINICAL TRIALS | Phase 2-4 | |
STUDY TEAM
Study Coordinators
The department is currently training 2 study coordinators.
Name | Phone | |
Nikoletta Egri | +36 72 507 300 | egri.nikoletta@pte.hu |
Gabriella Schober | +36 72 507 300 | schober.gabriella@pte.hu |
Study Nurses
Two study nurses are working at our department currently.
Number of study nurses with master degree (MSc): 0
Number of study nurses with bachelor degree (BSc): 0
Number of study nurses with further education degree: 2
Name | Phone | |
Csilla Gondos | +36 72 507 378 | gondos.csilla73@freemail.hu |
Andrea Hermann Horváthné | +36 72 507 300 | hermann.andrea@pte.hu |
Created: 02/08/2019.
Last updated: 09.04.2019.