Efficiency of Lina LibrataTM System

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Device: Use of the Lina LibrataTM


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lina LibrataTM<br>Use of the Lina LibrataTM | Device: Use of the Lina LibrataTM<br>* Use of the Lina LibrataTM<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of amenorrhea |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Pain at Hour 0 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain). | during surgery (Hour 0) | 
| pain score | Pain at Hour 2 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain). | 2 hours after surgery (Hour 2) | 
| pain score | Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine). | 6 hours after surgery (Hour 6) | 
| pain score | Pain at Hour 6 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).. | 6 hours after surgery (Hour 6) | 
| pain score | Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine). | the day after surgery (Day 1) | 
| pain score | Pain at Day 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain). | the day after surgery (Day 1) | 
| pain score | Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine) | one week after surgery (Day 7) | 
| pain score | Pain at Day 7 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain). | one week after surgery (Day 7) | 
| pain score | Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine) | one month after surgery (Month 1) | 
| pain score | Pain at Month 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain). | one month after surgery (Month 1) | 
| recurrences of menorrhagia |  | at month 1 | 
| recurrences of menorrhagia |  | at month 6 | 
| assessment of menorrhagia on Higham's score | Assessment by patients on Higham's score. A score greater than 100 points corresponds to bleeding greater than 80 ml of blood. | 1 month after surgery | 
| assessment of menorrhagia on Higham's score | Assessment by patients on Higham's score. A score greater than 100 points corresponds to bleeding greater than 80 ml of blood. | 6 months after surgery | 
| evolution of hemoglobinemia | hemoglobin measured by blood test | 1 month after surgery | 
| evolution of hemoglobinemia | hemoglobin measured by blood test | 6 months after surgery | 
| per-operative complications |  | per surgery day 0 | 
| post-operative complications |  | post surgery day 0 | 
| measure of quality of life | assessed by the questionnaire SF-12 (abridged version of the Medical Outcomes Study Short-Form General Health Survey SF-36). It allows to obtain 2 scores: mental and social score (from 5.89058 to 71.966825) and physical score (from 9.94738 to 70.02246). The average of this scores in the general population is 50. | at month 1 | 
| measure of quality of life | assessed by the questionnaire SF-12 (abridged version of the Medical Outcomes Study Short-Form General Health Survey SF-36). It allows to obtain 2 scores: mental and social score (from 5.89058 to 71.966825) and physical score (from 9.94738 to 70.02246). The average of this scores in the general population is 50. | at month 6 | 
| measure of symptoms improvement | assessed by the questionnaire PGI-I (from 1 much better to 7 much worse) | at month 1 | 
| measure of symptoms improvement | assessed by the questionnaire PGI-I (from 1 much better to 7 much worse) | at month 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menorrhagia, Lina LibrataTM, efficiency, menometrorrhagia