Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 1:21 PM
Study NCT ID:
NCT01979835
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2013-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance
Sponsor:
Wiebe, Ellen, M.D.
Organization:
Study Overview
Official Title:
GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION
Status:
COMPLETED
Status Verified Date:
2020-04
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:
GF
Brief Summary:
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.
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?: