Triamcinolone Levels in Cochlear Perilymph
2 other identifiers
interventional
40
1 country
1
Brief Summary
In this study Triamcinolone acetonide will be applied intratympanically before cochlear implant surgery. After round window exposure, a perilymph sample and simultaneously a blood sample will be drawn. Triamcinolone levels will then be analyzed in the samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedSeptember 28, 2021
September 1, 2021
3.2 years
August 9, 2017
September 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Triamcinolone levels in comparison
Absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation
2 years
Secondary Outcomes (3)
Triamcinolone stability
2 years
Triamcinolone concentrations
2 years
Impedances
2 years
Study Arms (4)
Group 1
OTHERGroup 1 will receive triamcinolone acetonide 10mg 20 to 24hours before sampling.
Group 2
OTHERGroup 2 will receive triamcinolone acetonide 40mg 20 to 24hours before sampling.
Group 3
OTHERGroup 3 will receive triamcinolone acetonide 10mg 1 to 2 hours before sampling.
Group 4
OTHERGroup 3 will receive triamcinolone acetonide 40mg 1 to 2 hours before sampling.
Interventions
Eligibility Criteria
You may qualify if:
- Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study
You may not qualify if:
- Patients younger than 18 years
- Patients who receive cortisone on a regular basis or receive cortisone i.v. or p.o. preoperatively
- Patients with contraindications against the administration of Volon A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna (AKH)
Vienna, 1090, Austria
Related Publications (1)
Dahm V, Gausterer JC, Auinger AB, Honeder C, Gabor F, Reznicek G, Kaider A, Riss D, Arnoldner C. Evaluation of Levels of Triamcinolone Acetonide in Human Perilymph and Plasma After Intratympanic Application in Patients Receiving Cochlear Implants: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Nov 1;147(11):974-980. doi: 10.1001/jamaoto.2021.2492.
PMID: 34591079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assoc Prof PD Dr.
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 14, 2017
Study Start
October 2, 2017
Primary Completion
December 31, 2020
Study Completion
May 31, 2021
Last Updated
September 28, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- January 2020