Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-01 @ 11:11 AM
Study NCT ID:
NCT02762357
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
Sponsor:
Aesculap AG
Organization:
Study Overview
Official Title:
Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.
Status:
COMPLETED
Status Verified Date:
2020-07
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:
EPINOQ
Brief Summary:
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: