NCT03670680

Brief Summary

Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia . In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

September 4, 2018

Last Update Submit

January 20, 2026

Conditions

Menorrhagia

Keywords

MenorrhagiaLina LibrataTMefficiencymenometrorrhagia

Outcome Measures

Primary Outcomes (1)

  • rate of amenorrhea

    4 weeks

Secondary Outcomes (22)

  • pain score

    during surgery (Hour 0)

  • pain score

    2 hours after surgery (Hour 2)

  • pain score

    6 hours after surgery (Hour 6)

  • pain score

    6 hours after surgery (Hour 6)

  • pain score

    the day after surgery (Day 1)

  • +17 more secondary outcomes

Study Arms (1)

Lina LibrataTM

EXPERIMENTAL

Use of the Lina LibrataTM

Device: Use of the Lina LibrataTM

Interventions

Use of the Lina LibrataTMDEVICE

Use of the Lina LibrataTM

Lina LibrataTM

Eligibility Criteria

Age38 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women from 40 to 50 years old
  • Not menopausal women
  • Do not want pregnancy
  • Having dysfunctional bleeding
  • informed and signed consent

You may not qualify if:

  • Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc
  • Pregnancy or wish to have later pregnancy
  • Endometrium cancer (or suspicious of cancer) or precancerous conditions of the endometrium
  • Anatomical conditions (i-e history of caesarian, transmural myomectomy) or pathological conditions (i-e long term treatment) which can weaken myometrium
  • Genital or urinary infection at the time of the procedure
  • Intra uterine device
  • Pelvic inflammation
  • Inability to understand information provided
  • Not covered by a national health insurance scheme, prisoner or under administrative supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Géry LAMBLIN, MD

    Hospices Civils de Lyon Gynaecology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 13, 2018

Study Start

October 16, 2018

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

FR(1)