Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545175
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Intracochlear Application of VSF101 for the Reduction of Cochlear Implant Surgery Related Trauma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Extracellular Vesicle-enriched Secretome Fraction VSF101 for the Reduction of Cochlear Implant Surgery Related Trauma ESCRT an Open-label Monocentric Phase IIIa Clinical Trial to Investigate the Safety of Intracochlear Application of VSF101 Enriched with HUC-MSC-EVs in Patients Receiving Cochlear Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCRT
Brief Summary:
The goal of this clinical trial is to assess the safety of intracochlear application of VSF101 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation
The main questions it aims to answer are
Primary objective
Safety of intracochlear application of VSF101 in patients receiving cochlear implantation
Secondary objectives
Effectiveness on
1 neural responses of auditory nerve
2 speech understanding
3 hearing thresholds
4 electrode impedances
During cochlear implant operation patients receive as adjuvant treatment intracochlear VSF101 prior to insertion of the electrode array
Cochlear implantation is conducted according to the clinical standard at the investigational site
The main questions it aims to answer are
Primary objective
Safety of intracochlear application of VSF101 in patients receiving cochlear implantation
Secondary objectives
Effectiveness on
1 neural responses of auditory nerve
2 speech understanding
3 hearing thresholds
4 electrode impedances
During cochlear implant operation patients receive as adjuvant treatment intracochlear VSF101 prior to insertion of the electrode array
Cochlear implantation is conducted according to the clinical standard at the investigational site
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None