Efficiency of Lina LibrataTM System

NCT ID: NCT03670680

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2025-09-30

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.

Conditions

Menorrhagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lina LibrataTM

Use of the Lina LibrataTM

Group Type: EXPERIMENTAL

Use of the Lina LibrataTM

Intervention Type: DEVICE

Use of the Lina LibrataTM

Interventions

Use of the Lina LibrataTM

Use of the Lina LibrataTM

Intervention Type: DEVICE

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

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Géry LAMBLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon Gynaecology Department

Locations

Hospices Civils de Lyon

Bron, , France

Countries

France

Other Identifiers

2017-A02017-46

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0266

Identifier Type: -

Identifier Source: org_study_id