Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

NCT03725306 | Unknown Phase 3 DMC

• 1 other identifier: LEADER NA
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menorrhagia; Heavy Menstrual Bleeding

Keywords

Heavy Menstrual Bleeding; Endometrial Ablation

Outcome Measures

Primary Outcomes (2)

• Change in Menstrual Bleeding

  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.

  12 months post-treatment

• Incidence of serious adverse events (SAEs).

  The primary safety endpoint

  12 months post-treatment

Secondary Outcomes (5)

• Changes in Quality of Life

  12 months

• Procedure Time

  During procedure

• Menstrual Blood Loss

  3, 6, 12, 24 and 36 months

• Rates of Re-Intervention

  Month 12

• Incidence of Unanticipated Adverse Device Effects (UADEs)

  Month 12

Study Arms (1)

Librata

EXPERIMENTAL

Librata Endometrial Ablation Device

Device: Librata

Interventions

Librata DEVICE

Hyperthermic endomyometrial treatment via Librata catheter and balloon device

Librata

Eligibility Criteria

• Age: 25 Years - 50 Years
• Gender Eligibility Details: Pre-menopausal women for whom childbearing is complete
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)

Sponsors & Collaborators

• LiNA Medical: lead
• Syntactx: collaborator
• West Virginia University, Pathology Laboratory for Translational Medicine: collaborator
• Infinite Clinical Research, S.A. de C.V.: collaborator

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Claude Fortin, MD

  LaSalle, QC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Cox

CONTACT

6175964183; bco@lina-medical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Objective Performance Criterion

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: January 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share