Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634784
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation
Status:
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:
2023BB006
Brief Summary:
This study titled The BONEBRIDGE in Children Under Five Premarket Clinical Investigation Study ID 2023BB006 looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant This observational study which is both retrospective looking back and prospective looking forward will take place at multiple hospitals The main goal is to see if the BONEBRIDGE implant is safe for young children within 12 months after surgery
Primary Goal The studys main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety
Secondary Goals
Hearing Improvement Using tests like the Göttinger Speech Intelligibility Test Word Recognition Scores to see how much the hearing improves with the implant
Treatment History Surgeons will fill out questionnaires about how the treatment went
Quality of Life Parents will answer questions about their childs quality of life using the GCBI questionnaire at least 12 months after the implant
The study will last up to 12 months including enrolling participants and performing all necessary procedures The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data
By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant this study aims to determine if it is safe and effective for young children
Primary Goal The studys main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety
Secondary Goals
Hearing Improvement Using tests like the Göttinger Speech Intelligibility Test Word Recognition Scores to see how much the hearing improves with the implant
Treatment History Surgeons will fill out questionnaires about how the treatment went
Quality of Life Parents will answer questions about their childs quality of life using the GCBI questionnaire at least 12 months after the implant
The study will last up to 12 months including enrolling participants and performing all necessary procedures The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data
By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant this study aims to determine if it is safe and effective for young children
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