Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375278
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Brief Title:
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
Sponsor:
Restorear Devices LLC
Organization:
Restorear Devices LLC
Study Overview
Official Title:
Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery The main questions the trial aims to answer are
1 Is mild therapeutic hypothermia safe for use during cochlear implantation
2 Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation
Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery Researchers will compare results from those receiving the therapy to those from a control group individuals receiving no therapy
1 Is mild therapeutic hypothermia safe for use during cochlear implantation
2 Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation
Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery Researchers will compare results from those receiving the therapy to those from a control group individuals receiving no therapy
Detailed Description:
Cochlear implants CI have dramatically changed the treatment and prognosis for patients with severe to profound sensorineural hearing loss With the recent advent of electro-acoustic stimulation EAS the combined acoustic amplification at low frequencies with electrical stimulation of high frequency cochlear regions promises to benefit patients with even partial residual hearing by improving difficult listening situations like speech-in-noise and music appreciation Unfortunately trauma associated with the implant surgery results in inflammation mechanical and vascular damage and loss of remaining sensory hair cells HC and neurons As a result more than 44 of EAS patients lose residual hearing post-CI surgery and the residual hearing deteriorates by more than 30 dB over time in a majority of patients This loss of residual hearing post-CI surgery has been the primary barrier for an extended application of CIEAS
This clinical trial will evaluate a novel mild therapeutic hypothermia device as an effective therapy to preserve residual hearing post-CI This system does not require modification of the current surgery or CI devices and will deliver localized controlled mild hypothermia to the sensitive inner ear structures With preclinical published results the investigators have already shown that localized hypothermia during CI surgery is highly effective and safe for residual hearing preservation Here the investigators will investigate the implementation of a therapy that benefits patients undergoing CI by improving post-surgical audiological outcomes Extensive prior commercialization and development experience intellectual property and engineering expertise coupled with the investigators39 collaborators clinical expertise in Otolaryngology and Audiology will ensure the successful clinical and commercial outcome of this therapy
Overall the aim of this clinical trial is
Validate the clinical applicability safety and efficacy of the system and device assembly for preservation of residual hearing after CI surgery The device and hypothermia delivery system will be tested on adult patients undergoing CI surgery at the University of Miami For clinical translation the investigators aim to demonstrate that the application of hypothermia combined with the current standard of care for cochlear implantation for residual hearing preservation steroids is effective The investigators hypothesize that the hypothermia application will not negatively impact CI function in patients safety and will improve early audiologic outcomes efficacy compared to the current standard of care in CI surgeries The investigators will utilize clinically relevant pre-surgical intra-operative and post-surgical measures in groups of patients receiving the standard of care and hypothermia therapy
Preliminary and published preclinical data and an existing system and device have been constructed for this clinical trial The proposed therapy and device design for CI surgeries represent a non-pharmaceutical therapeutic strategy to preserve residual hearing
This clinical trial will evaluate a novel mild therapeutic hypothermia device as an effective therapy to preserve residual hearing post-CI This system does not require modification of the current surgery or CI devices and will deliver localized controlled mild hypothermia to the sensitive inner ear structures With preclinical published results the investigators have already shown that localized hypothermia during CI surgery is highly effective and safe for residual hearing preservation Here the investigators will investigate the implementation of a therapy that benefits patients undergoing CI by improving post-surgical audiological outcomes Extensive prior commercialization and development experience intellectual property and engineering expertise coupled with the investigators39 collaborators clinical expertise in Otolaryngology and Audiology will ensure the successful clinical and commercial outcome of this therapy
Overall the aim of this clinical trial is
Validate the clinical applicability safety and efficacy of the system and device assembly for preservation of residual hearing after CI surgery The device and hypothermia delivery system will be tested on adult patients undergoing CI surgery at the University of Miami For clinical translation the investigators aim to demonstrate that the application of hypothermia combined with the current standard of care for cochlear implantation for residual hearing preservation steroids is effective The investigators hypothesize that the hypothermia application will not negatively impact CI function in patients safety and will improve early audiologic outcomes efficacy compared to the current standard of care in CI surgeries The investigators will utilize clinically relevant pre-surgical intra-operative and post-surgical measures in groups of patients receiving the standard of care and hypothermia therapy
Preliminary and published preclinical data and an existing system and device have been constructed for this clinical trial The proposed therapy and device design for CI surgeries represent a non-pharmaceutical therapeutic strategy to preserve residual hearing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44DC019586 | NIH | None | httpsreporternihgovquickSearch5R44DC019586 |