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NCT05615649 · ClinicalTrials.gov registry record · NA
Expanded Indications in the Pediatric BONEBRIDGE Population
A NA study of Hearing Loss, Conductive and Hearing Loss, Mixed, sponsored by Med-El Corporation.
- Active
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT05615649: Active NA study of Hearing Loss, Conductive and Hearing Loss, Mixed, sponsored by Med-El Corporation.
NCT05615649 is a NA study of Hearing Loss, Conductive and Hearing Loss, Mixed that is active but no longer recruiting, run by Med-El Corporation. The registered enrollment target is 36 participants, below the 3,539-participant average among 4 other Hearing Loss, Conductive trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05615649, a NA study of Hearing Loss, Conductive and Hearing Loss, Mixed, is active but no longer recruiting, sponsored by Med-El Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
Primary Outcome
Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds
Conditions Studied
Interventions
- DEVICE MED-EL BONEBRIDGE Bone Conduction Implant
Study Locations (6)
Colorado
- University of Colorado Health/Children's Hospital of Colorado - Aurora
Florida
- University of Miami - Miami
New Jersey
- University Hospital Newark/Rutgers New Jersey Medical School - Newark
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- The Ohio State University/Nationwide Children's Hospital - Columbus
Utah
- University of Utah Health/Primary Children's Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-10-03 |
| Est. Completion | 2026-07 |
| Phase | NA |
What the registry record for NCT05615649 still lists
NCT05615649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 3,539-participant average among 4 other Hearing Loss, Conductive trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Hearing Loss, Conductive appearing as the primary indexed condition, and to 1 intervention - of which MED-EL BONEBRIDGE Bone Conduction Implant is the first listed.
NCT05615649 lists 6 locations in 6 states (Colorado, Florida, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05615649 about?
NCT05615649 is a clinical study titled "Expanded Indications in the Pediatric BONEBRIDGE Population". This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
What is the current status of trial NCT05615649?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2023-10-03. Estimated completion is 2026-07.
What conditions does trial NCT05615649 study?
This clinical trial studies the following conditions: Hearing Loss, Conductive, Hearing Loss, Mixed.
What interventions are being tested in trial NCT05615649?
The interventions under investigation include: MED-EL BONEBRIDGE Bone Conduction Implant (DEVICE).
Who is sponsoring clinical trial NCT05615649?
This trial is sponsored by Med-El Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05615649 being conducted?
This trial has 6 study locations across Colorado, Florida, New Jersey, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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