Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

Phase 3

• Conditions: Menorrhagia; Heavy Menstrual Bleeding
• Interventions: Device: Librata

• Registration Number: NCT03725306
• Lead Sponsor: LiNA Medical

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.

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07
• Study Start: 2019-01-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Librata	Librata	Librata Endometrial Ablation Device

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs).	12 months post-treatment	The primary safety endpoint
Change in Menstrual Bleeding	12 months post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life	12 months	Responses from quality of life questionnaires
Rates of Re-Intervention	Month 12	Rate of repeat ablation and/or hysterectomy surgery
Menstrual Blood Loss	3, 6, 12, 24 and 36 months	Menstrual blood loss assessment
Procedure Time	During procedure	Librata ablation procedure time
Incidence of Unanticipated Adverse Device Effects (UADEs)	Month 12