Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

NCT ID: NCT03725306

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-12-01

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.

Conditions

Menorrhagia; Heavy Menstrual Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Librata

Librata Endometrial Ablation Device

Group Type: EXPERIMENTAL

Librata

Intervention Type: DEVICE

Hyperthermic endomyometrial treatment via Librata catheter and balloon device

Interventions

Librata

Hyperthermic endomyometrial treatment via Librata catheter and balloon device

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

To be enrolled, candidates should NOT meet any exclusion criterion:

• Pregnancy or subject with a desire to become pregnant
• Endometrial hyperplasia as confirmed by histology
• Presence of active endometritis
• Active pelvic inflammatory disease
• Active sexually transmitted disease (STD), at the time of ablation.

o Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.

• Presence of bacteremia, sepsis, or other active systemic infection
• Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
• Known/suspected gynecological malignancy within the past 5 years
• Known clotting defects or bleeding disorders
• Untreated/unevaluated cervical dysplasia (except CIN I)
• Known/suspected abdominal/pelvic cancer
• Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
• Previous endometrial ablation procedure
• Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
• Currently on anticoagulants
• Abnormal or obstructed cavity as confirmed by transvaginal ultrasound +/- hysteroscopy - specifically:

1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity

2. Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity

3. Polyps >2 cm in maximum diameter

4. Any intramural myoma > 3 cm or which distorts the uterine cavity

• Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit
• Presence of an implanted contraceptive device (e.g. Essure or Adiana).
• Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation
• Subject wanting concomitant hysteroscopic sterilization
• Subject who is within 6-weeks post-partum
• Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
• Any subject who is currently participating in the primary endpoint phase of an on-going investigational drug or device study or intends future participation in any other research of an investigational drug or device during the primary endpoint phase of this study

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Syntactx

NETWORK

Sponsor Role: collaborator

West Virginia University, Pathology Laboratory for Translational Medicine

UNKNOWN

Sponsor Role: collaborator

Infinite Clinical Research, S.A. de C.V.

INDUSTRY

Sponsor Role: collaborator

LiNA Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claude Fortin, MD

Role: PRINCIPAL_INVESTIGATOR

LaSalle, QC

Central Contacts

Barbara Cox

Role: CONTACT

bco@lina-medical.com

6175964183

Other Identifiers

LEADER NA

Identifier Type: -

Identifier Source: org_study_id