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Completed

NCT Number: NCT03670680

Efficiency of Lina LibrataTM System

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

38 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of the Lina LibrataTM

Device

Use of the Lina LibrataTM

Primary outcomes

  1. rate of amenorrhea

    Time frame: 4 weeks

Secondary outcomes

  1. 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).

  2. 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).

  3. pain score

    Time frame: 6 hours after surgery (Hour 6)

    Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).

  4. 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)..

  5. pain score

    Time frame: the day after surgery (Day 1)

    Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).

  6. 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).

  7. pain score

    Time frame: one week after surgery (Day 7)

    Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)

  8. 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).

  9. pain score

    Time frame: one month after surgery (Month 1)

    Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)

  10. 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).

  11. recurrences of menorrhagia

    Time frame: at month 1

  12. recurrences of menorrhagia

    Time frame: at month 6

  13. 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.

  14. 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.

  15. evolution of hemoglobinemia

    Time frame: 1 month after surgery

    hemoglobin measured by blood test

  16. evolution of hemoglobinemia

    Time frame: 6 months after surgery

    hemoglobin measured by blood test

  17. per-operative complications

    Time frame: per surgery day 0

  18. post-operative complications

    Time frame: post surgery day 0

  19. 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.

  20. 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.

  21. measure of symptoms improvement

    Time frame: at month 1

    assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")

  22. measure of symptoms improvement

    Time frame: at month 6

    assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: THERMOLIB

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2018
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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