Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 11:11 AM
Study NCT ID:
NCT03266094
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Sponsor:
Medtronic - MITG
Organization:
Study Overview
Official Title:
A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
Status:
COMPLETED
Status Verified Date:
2020-05
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 assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.
Detailed Description:
A prospective, multi-center, single arm, study of BiZact™ on children and adolescents undergoing tonsillectomy.
Study Visits:
* Screening/Baseline
* Surgery, Day 0
* Post-Op Follow-up Day 1 - Day 7, Day 10, \& Day 14 (Home assessments)
* Post-Op Follow-up Day 28 (Office Visit)
Study Visits:
* Screening/Baseline
* Surgery, Day 0
* Post-Op Follow-up Day 1 - Day 7, Day 10, \& Day 14 (Home assessments)
* Post-Op Follow-up Day 28 (Office Visit)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: