Clinical trial NCT03670680: Efficiency of Lina LibrataTM System
Official title: Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Menorrhagia
Keywords: Menorrhagia
Lina LibrataTM
efficiency
menometrorrhagia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 38
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: rate of amenorrhea
timeFrame: 4 weeks
Secondary outcomes:
measure: pain score
timeFrame: during surgery (Hour 0)
measure: pain score
timeFrame: 2 hours after surgery (Hour 2)
measure: pain score
timeFrame: 6 hours after surgery (Hour 6)
measure: pain score
timeFrame: 6 hours after surgery (Hour 6)
measure: pain score
timeFrame: the day after surgery (Day 1)
measure: pain score
timeFrame: the day after surgery (Day 1)
measure: pain score
timeFrame: one week after surgery (Day 7)
measure: pain score
timeFrame: one week after surgery (Day 7)
measure: pain score
timeFrame: one month after surgery (Month 1)
measure: pain score
timeFrame: one month after surgery (Month 1)
measure: recurrences of menorrhagia
timeFrame: at month 1
measure: recurrences of menorrhagia
timeFrame: at month 6
measure: assessment of menorrhagia on Higham's score
timeFrame: 1 month after surgery
measure: assessment of menorrhagia on Higham's score
timeFrame: 6 months after surgery
measure: evolution of hemoglobinemia
timeFrame: 1 month after surgery
measure: evolution of hemoglobinemia
timeFrame: 6 months after surgery
measure: per-operative complications
timeFrame: per surgery day 0
measure: post-operative complications
timeFrame: post surgery day 0
measure: measure of quality of life
timeFrame: at month 1
measure: measure of quality of life
timeFrame: at month 6
measure: measure of symptoms improvement
timeFrame: at month 1
measure: measure of symptoms improvement
timeFrame: at month 6
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon Gynaecology Department
name: Géry LAMBLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: