- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03306108
Correlation Between NRT and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea.
Correlation Between the Neural Response Telemetry (NRT) and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea
The study will be conducted as Prospective study including 50 patients (aged <6years ) at Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements & postoperative CT imaging will be obtained.
Each patient will be subjected to the following scheme:
- immediate postoperative Neural Response Telemetry (NRT) measurements
- postoperative CT imaging
- Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, Assiut university71515
- Assiut university hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study will be conducted as Prospective study at Otorhinolaryngology department, Assuit University Hospital .. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. which will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative NRT measurements & postoperative CT imaging will be obtained.
Each patient will be subjected to the following scheme:
- immediate postoperative NRT measurements
- postoperative CT imaging
- Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.
Description
Inclusion Criteria:
- patients aged < 6years who will undergo cochlear implantation
Exclusion Criteria:
- Revision cochlear implantation.
- incomplete post-operative electrophysiological measurements.
- unfit patients for surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions
Time Frame: Baseline
|
The study will be conducted as Prospective study including 50 patients (aged <6years ) at Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements & postoperative CT imaging will be obtained. Each patient will be subjected to the following scheme:
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohammed Abd El - Aziz, Prof
Publications and helpful links
General Publications
- Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Lang S, Arweiler-Harbeck D, Christov F. Radiological and NRT-Ratio-Based Estimation of Slim Straight Cochlear Implant Electrode Positions: A Multicenter Study. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):73-78. doi: 10.1177/0003489416675355. Epub 2016 Oct 25.
- Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Ramalingam R, Lang S, Christov F, Arweiler-Harbeck D. Electrophysiological detection of scalar changing perimodiolar cochlear electrode arrays: a long term follow-up study. Eur Arch Otorhinolaryngol. 2016 Dec;273(12):4251-4256. doi: 10.1007/s00405-016-4175-2. Epub 2016 Jun 28.
- Lathuilliere M, Merklen F, Piron JP, Sicard M, Villemus F, Menjot de Champfleur N, Venail F, Uziel A, Mondain M. Cone-beam computed tomography in children with cochlear implants: The effect of electrode array position on ECAP. Int J Pediatr Otorhinolaryngol. 2017 Jan;92:27-31. doi: 10.1016/j.ijporl.2016.10.033. Epub 2016 Oct 31.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NRT in Cochlear implantation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cochlear Function Disorder
-
UPECLIN HC FM Botucatu UnespCompletedCochlear FunctionBrazil
-
Duke UniversityCompletedVestibular Function in Cochlear Implant PatientsUnited States
-
Centre Hospitalier Universitaire DijonCompletedUnilateral Cochlear Implants | Bilateral Cochlear ImplantsFrance
-
Universidad Católica San Antonio de MurciaEvonik Operations GmbHCompletedJoint Function DisorderSpain
-
Hospital de Clinicas de Porto AlegreActive, not recruitingRenal Function DisorderBrazil
-
Sun Yat-sen UniversityWithdrawnRenal Function DisorderChina
-
Sun Yat-sen UniversityCompletedRenal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis PatientsRenal Function DisorderChina
-
University of MalayaNot yet recruitingRenal Function DisorderMalaysia
-
Sun Yat-sen UniversityBeijing Fresenius Kabi Pharmaceutical CoCompletedRenal Function DisorderChina
-
Hôpital Necker-Enfants MaladesBambino Gesù Hospital and Research InstituteTerminatedAcquired Platelet Function DisorderFrance
Clinical Trials on NRT
-
University of OklahomaNational Cancer Institute (NCI)Completed
-
University of HoustonUniversity of OklahomaRecruiting
-
University of OklahomaRecruiting
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Unknown
-
Meharry Medical CollegeNational Institute on Drug Abuse (NIDA); Medical University of South CarolinaActive, not recruiting
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA); University of UtahRecruitingTobacco Use | Opioid Use | Polysubstance AbuseUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)Enrolling by invitation
-
Kaiser PermanenteNational Cancer Institute (NCI); Department of Human Services, OregonCompletedSmoking Cessation | Tobacco Use Cessation | Cost-effectivenessUnited States
-
University of KentuckyKentucky Lung Cancer Research ProgramCompletedHead and Neck Cancer | Lung CancerUnited States
-
University of Massachusetts, WorcesterNational Cancer Institute (NCI)CompletedSmoking CessationUnited States