Efficiency of Lina LibrataTM System (THERMOLIB)

January 25, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon
        • Principal Investigator:
          • Géry LAMBLIN, MD
        • Sub-Investigator:
          • Gautier CHENE, MD
        • Sub-Investigator:
          • Philippe CHABERT, MD
        • Sub-Investigator:
          • Karine LEBAIL-CARVAL, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Etienne BEAUFILS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lina LibrataTM
Use of the Lina LibrataTM
Use of the Lina LibrataTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of amenorrhea
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: during surgery (Hour 0)
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
Time Frame: 2 hours after surgery (Hour 2)
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
Time Frame: 6 hours after surgery (Hour 6)
Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
6 hours after surgery (Hour 6)
pain score
Time Frame: 6 hours after surgery (Hour 6)
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
Time Frame: the day after surgery (Day 1)
Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
the day after surgery (Day 1)
pain score
Time Frame: the day after surgery (Day 1)
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
Time Frame: one week after surgery (Day 7)
Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
one week after surgery (Day 7)
pain score
Time Frame: one week after surgery (Day 7)
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
Time Frame: one month after surgery (Month 1)
Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
one month after surgery (Month 1)
pain score
Time Frame: one month after surgery (Month 1)
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
Time Frame: at month 1
at month 1
recurrences of menorrhagia
Time Frame: at month 6
at month 6
assessment of menorrhagia on Higham's score
Time Frame: 1 month after surgery
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
Time Frame: 6 months after surgery
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
Time Frame: 1 month after surgery
hemoglobin measured by blood test
1 month after surgery
evolution of hemoglobinemia
Time Frame: 6 months after surgery
hemoglobin measured by blood test
6 months after surgery
per-operative complications
Time Frame: per surgery day 0
per surgery day 0
post-operative complications
Time Frame: post surgery day 0
post surgery day 0
measure of quality of life
Time Frame: at month 1
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
Time Frame: at month 6
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
Time Frame: at month 1
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
at month 1
measure of symptoms improvement
Time Frame: at month 6
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
at month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Géry LAMBLIN, MD, Hospices Civils de Lyon Gynaecology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Estimated)

October 16, 2025

Study Completion (Estimated)

October 16, 2025

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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