Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT03725306
Status:
UNKNOWN
Last Update Posted:
2018-11-07
First Post:
2018-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss
Sponsor:
LiNA Medical
Organization:
Study Overview
Official Title:
Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss
Status:
UNKNOWN
Status Verified Date:
2018-11
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:
LEADER
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of the endometrial ablation device Librata in reducing menstrual blood loss at 12 months post-treatment when used in pre-menopausal women with menorrhagia due to benign causes for whom childbearing is complete.
Detailed Description:
Menorrhagia is ovulatory (cyclic), heavy bleeding, that should be treated when it interferes with quality of life or causes anemia. It is a common problem and it is estimated that 5% of women aged 30 to 49 seek referral for evaluation and treatment. No structural cause is found in the majority of women with menorrhagia and treatment intends to reduce blood loss and improve quality of life.
First line treatment is medical therapy with hormonal therapy using either the combined contraceptive pill or the levonorgestrel-releasing intrauterine system. These treatments are not suitable for all women and indeed some women may not find them acceptable. For these women, surgical management is then offered with either endometrial ablation or hysterectomy.
The primary objective of this study is to evaluate the clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary at 12 months post-treatment. Additionally, a secondary objective is to determine the primary safety incidence of serious adverse events (SAEs) by 12 months.
The study is designed as a prospective, multi-center, single-arm, controlled trial to demonstrate that the percentage of subjects with reduction in menstrual bleeding at 12 months is significantly greater than 66%. A total of 200 subjects will be enrolled.
The study population will include pre-menopausal women, aged 25-50 with a history of menorrhagia due to benign causes for whom childbearing is complete.
First line treatment is medical therapy with hormonal therapy using either the combined contraceptive pill or the levonorgestrel-releasing intrauterine system. These treatments are not suitable for all women and indeed some women may not find them acceptable. For these women, surgical management is then offered with either endometrial ablation or hysterectomy.
The primary objective of this study is to evaluate the clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary at 12 months post-treatment. Additionally, a secondary objective is to determine the primary safety incidence of serious adverse events (SAEs) by 12 months.
The study is designed as a prospective, multi-center, single-arm, controlled trial to demonstrate that the percentage of subjects with reduction in menstrual bleeding at 12 months is significantly greater than 66%. A total of 200 subjects will be enrolled.
The study population will include pre-menopausal women, aged 25-50 with a history of menorrhagia due to benign causes for whom childbearing is complete.
Study Oversight
Has Oversight DMC:
True
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?: