Efficiency of Lina LibrataTM System

Menorrhagia Clinical Trial

— THERMOLIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670680
• Other study ID #: 69HCL17_0266
• Secondary ID: 2017-A02017-46
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: October 16, 2025

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Géry LAMBLIN, MD
• Phone: 472 35 58 71
• Email: gery.lamblin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: October 16, 2025
• Est. primary completion date: October 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 38 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• Use of the Lina LibrataTM
Use of the Lina LibrataTM

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of amenorrhea		4 weeks
Secondary	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)
Secondary	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)
Secondary	pain score	Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).	6 hours after surgery (Hour 6)
Secondary	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)
Secondary	pain score	Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).	the day after surgery (Day 1)
Secondary	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)
Secondary	pain score	Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)	one week after surgery (Day 7)
Secondary	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)
Secondary	pain score	Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)	one month after surgery (Month 1)
Secondary	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)
Secondary	recurrences of menorrhagia		at month 1
Secondary	recurrences of menorrhagia		at month 6
Secondary	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
Secondary	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
Secondary	evolution of hemoglobinemia	hemoglobin measured by blood test	1 month after surgery
Secondary	evolution of hemoglobinemia	hemoglobin measured by blood test	6 months after surgery
Secondary	per-operative complications		per surgery day 0
Secondary	post-operative complications		post surgery day 0
Secondary	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
Secondary	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
Secondary	measure of symptoms improvement	assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")	at month 1
Secondary	measure of symptoms improvement	assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")	at month 6