Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283498
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-01
First Post:
2024-02-21
Brief Title:
Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
Sponsor:
InMode MD Ltd
Organization:
InMode MD Ltd
Study Overview
Official Title:
Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
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 goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms including refractory overactive bladder
The main questions it aims to answer are
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes Time Frame 3 months
Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment If less than a 50 improvement is noted a second and third treatment session will be performed at 4-week intervals If more than a 50 improvement is noted patients will be followed longitudinally to assess the durability of the treatment Investigators will have the ability to initiate a second and or third treatment on an individual basis
Follow-up will occur at 3- months 6-months and 12 months after the subjects last treatment
The main questions it aims to answer are
Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes Time Frame 3 months
Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment If less than a 50 improvement is noted a second and third treatment session will be performed at 4-week intervals If more than a 50 improvement is noted patients will be followed longitudinally to assess the durability of the treatment Investigators will have the ability to initiate a second and or third treatment on an individual basis
Follow-up will occur at 3- months 6-months and 12 months after the subjects last treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None