Efficiency of Lina LibrataTM System

  • STATUS
    Recruiting
  • End date
    Oct 16, 2023
  • participants needed
    38
  • sponsor
    Hospices Civils de Lyon
Updated on 23 January 2021
local anesthetic
uterine disease

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.

Details
Condition Menorrhagia, Hypomenorrhea, Menstrual Disorders
Treatment Use of the Lina LibrataTM
Clinical Study IdentifierNCT03670680
SponsorHospices Civils de Lyon
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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