Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-07 @ 10:52 AM
Study NCT ID:
NCT06478992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
Sponsor:
First People's Hospital of Hangzhou
Organization:
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.
Detailed Description:
This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.
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?: