Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT03082118
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2017-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vesair Continued Access Trial
Sponsor:
Solace Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2019-07
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:
VESICAL
Brief Summary:
Single arm study of the Vesair Balloon in postmenopausal women.
Detailed Description:
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.
Study Oversight
Has Oversight DMC:
False
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?: