Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06336304
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NXT Post-Market Clinical Follow-up
Sponsor:
Laborie Medical Technologies Inc.
Organization:
Study Overview
Official Title:
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
Status:
RECRUITING
Status Verified Date:
2025-02
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:
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
Detailed Description:
The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.
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?:
False
Is an FDA AA801 Violation?: