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Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

NCT03725306 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-11-07

No results posted yet for this study

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

Interventions

DEVICE

Librata

Hyperthermic endomyometrial treatment via Librata catheter and balloon device

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • West Virginia University, Pathology Laboratory for Translational Medicine

    collaborator UNKNOWN

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

    collaborator INDUSTRY

  • LiNA Medical

    lead INDUSTRY

Principal Investigators

  • Claude Fortin, MD · LaSalle, QC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-09-01
Completion
2022-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725306 on ClinicalTrials.gov