Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406452
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-02
Brief Title:
Bioresorbable Airway Splint Pivotal Clinical Trial
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects with Clinically Significant Tracheobronchomalacia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 purpose of this study is to learn if a three-dimensional 3D printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia TBM in children
The airway splint is bioresorbable meaning the childs body will absorb the splint over about five years
The airway splint is bioresorbable meaning the childs body will absorb the splint over about five years
Detailed Description:
Other sites will be added to the registration as sites are on-boarded
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?:
None
Is an FDA AA801 Violation?:
None