Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263985
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-01
Brief Title:
AxisTM Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse
Sponsor:
Michigan Institution of Womens Health PC
Organization:
Michigan Institution of Womens Health PC
Study Overview
Official Title:
Prospective Analysis of AxisTM Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
The goal of this study is to assess improvement in subjects who have undergone Axis Dermis biologic mesh for pelvic organ prolapse repair describe participant populationhealth conditions The main questions it aims to answer are
Is the leading edge of the prolapse above the hymen
Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure
Is the leading edge of the prolapse above the hymen
Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure
Detailed Description:
This is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the Axis Dermis biologic mesh They will be followed for a period of 3 years A subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy
Clinical examination including vaginal wall retraction with or without pelvic ultrasound POP-Q and also specific validated questionnaires at baseline 1 month 6 month 12 month 24 month and 36 month visits will be assessed
Clinical examination including vaginal wall retraction with or without pelvic ultrasound POP-Q and also specific validated questionnaires at baseline 1 month 6 month 12 month 24 month and 36 month visits will be assessed
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