Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT00737061
Status:
TERMINATED
Last Update Posted:
2017-09-08
First Post:
2008-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)
Sponsor:
Hologic, Inc.
Organization:
Study Overview
Official Title:
A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
Status:
TERMINATED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Product Pre-Market Approval withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
Brief Summary:
The purpose of this study is to demonstrate the safety \& efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
Detailed Description:
Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG) evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the Wearing Period of follow-up.
Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.
Secondary endpoints inlcude safety of device placement procedure and safety of device wearing. The adverse events recorded during the course of the study are entered under adverse events.
Study Oversight
Has Oversight DMC:
True
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?: