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Efficiency of Lina LibrataTM System (THERMOLIB)

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ClinicalTrials.gov Identifier: NCT03670680
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Menorrhagia Device: Use of the Lina LibrataTM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Experimental: Lina LibrataTM
Use of the Lina LibrataTM
Device: Use of the Lina LibrataTM
Use of the Lina LibrataTM




Primary Outcome Measures :
  1. rate of amenorrhea [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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")



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Ages Eligible for Study:   40 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670680


Contacts
Contact: Géry LAMBLIN, MD 472 35 58 71 ext +33 gery.lamblin@chu-lyon.fr
Contact: Stéphanie MORET stephanie.moret@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Not yet recruiting
Bron, France, 69500
Contact: Géry LAMBLIN    4 72 35 58 71 ext +33    gery.lamblin@chu-lyon.fr   
Contact: Stéphanie MORET       syephanie.moret@chu-lyon.fr   
Principal Investigator: Géry LAMBLIN, MD         
Sub-Investigator: Etienne BEAUFILS, MD         
Sub-Investigator: Philippe CHABERT, MD         
Sub-Investigator: Gautier CHENE, MD         
Sub-Investigator: Karine LEBAIL-CARVAL, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Géry LAMBLIN, MD Hospices Civils de Lyon Gynaecology Department

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03670680     History of Changes
Other Study ID Numbers: 69HCL17_0266
2017-A02017-46 ( Other Identifier: ID-RCB )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Menorrhagia
Lina LibrataTM
efficiency
menometrorrhagia

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes