Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02469584
Status:
UNKNOWN
Last Update Posted:
2015-06-11
First Post:
2015-06-05
Brief Title:
Small Stitch Study
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Continuous Small Stitch Technique for Anterior Colporrhaphy a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
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:
A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse POP Although anterior colporrhaphy AC is accepted worldwide as a standard procedure its exact steps are not well standardized
We developed a small stitch anterior colporrhaphy SSTAC in an effort to increase the strength and durability of AC
Objectives
The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair
We developed a small stitch anterior colporrhaphy SSTAC in an effort to increase the strength and durability of AC
Objectives
The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair
Detailed Description:
A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration wwwideal-collaborationnet will be performed The newly developed procedure will be tested in a group of 10 patients who equals stage 2a in the development and innovation of surgical innovations In this stage safety and technical success is the main outcome As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded the videotaping during all surgical procedures will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None