Viewing Study NCT05000112


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Ignite Modification Date: 2026-01-01 @ 4:45 AM
Study NCT ID: NCT05000112
Status: UNKNOWN
Last Update Posted: 2021-09-27
First Post: 2021-08-03
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Vaginal Microbiome-host Interaction in Mesh Exposure After TVM Surgery
Sponsor: Peking Union Medical College Hospital
Organization:

Study Overview

Official Title: The Influence of Vaginal Microbiome-host Interaction in the Mechanism of Mesh Exposure After Trans-Vaginal Mesh Implantation
Status: UNKNOWN
Status Verified Date: 2021-07
Last Known Status: NOT_YET_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: Transvaginal pelvic mesh implantation(TVM) is a foreign body implantation operation with intraoperative colonization of vaginal bacteria. However, the vaginal microbiome-host interaction and its influence in the mechanism of mesh exposure after TVM remains unclear. This study will enroll post-TVM patients with and without mesh exposure and use their vaginal swabs to perform TRACE-seq and cytokine analysis. The microbiome-host interactions related with mesh exposure and the changes in protein expression will be analyzed.
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: