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Efficiency of Lina LibrataTM System (THERMOLIB)

Primary Purpose

Menorrhagia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of the Lina LibrataTM
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Menorrhagia, Lina LibrataTM, efficiency, menometrorrhagia

Eligibility Criteria

38 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lina LibrataTM

Arm Description

Use of the Lina LibrataTM

Outcomes

Primary Outcome Measures

rate of amenorrhea

Secondary Outcome Measures

pain score
Pain at Hour 0 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
pain score
Pain at Hour 2 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
pain score
Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
pain score
Pain at Hour 6 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain)..
pain score
Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
pain score
Pain at Day 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
pain score
Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
pain score
Pain at Day 7 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
pain score
Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
pain score
Pain at Month 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
recurrences of menorrhagia
recurrences of menorrhagia
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.
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.
evolution of hemoglobinemia
hemoglobin measured by blood test
evolution of hemoglobinemia
hemoglobin measured by blood test
per-operative complications
post-operative complications
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.
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.
measure of symptoms improvement
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
measure of symptoms improvement
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")

Full Information

First Posted
September 4, 2018
Last Updated
January 4, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03670680
Brief Title
Efficiency of Lina LibrataTM System
Acronym
THERMOLIB
Official Title
Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
October 16, 2025 (Anticipated)
Study Completion Date
October 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Menorrhagia, Lina LibrataTM, efficiency, menometrorrhagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lina LibrataTM
Arm Type
Experimental
Arm Description
Use of the Lina LibrataTM
Intervention Type
Device
Intervention Name(s)
Use of the Lina LibrataTM
Intervention Description
Use of the Lina LibrataTM
Primary Outcome Measure Information:
Title
rate of amenorrhea
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
pain score
Description
Pain at Hour 0 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time Frame
during surgery (Hour 0)
Title
pain score
Description
Pain at Hour 2 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time Frame
2 hours after surgery (Hour 2)
Title
pain score
Description
Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
Time Frame
6 hours after surgery (Hour 6)
Title
pain score
Description
Pain at Hour 6 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain)..
Time Frame
6 hours after surgery (Hour 6)
Title
pain score
Description
Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
Time Frame
the day after surgery (Day 1)
Title
pain score
Description
Pain at Day 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time Frame
the day after surgery (Day 1)
Title
pain score
Description
Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
Time Frame
one week after surgery (Day 7)
Title
pain score
Description
Pain at Day 7 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time Frame
one week after surgery (Day 7)
Title
pain score
Description
Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
Time Frame
one month after surgery (Month 1)
Title
pain score
Description
Pain at Month 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Time Frame
one month after surgery (Month 1)
Title
recurrences of menorrhagia
Time Frame
at month 1
Title
recurrences of menorrhagia
Time Frame
at month 6
Title
assessment of menorrhagia on Higham's score
Description
Assessment by patients on Higham's score. A score greater than 100 points corresponds to bleeding greater than 80 ml of blood.
Time Frame
1 month after surgery
Title
assessment of menorrhagia on Higham's score
Description
Assessment by patients on Higham's score. A score greater than 100 points corresponds to bleeding greater than 80 ml of blood.
Time Frame
6 months after surgery
Title
evolution of hemoglobinemia
Description
hemoglobin measured by blood test
Time Frame
1 month after surgery
Title
evolution of hemoglobinemia
Description
hemoglobin measured by blood test
Time Frame
6 months after surgery
Title
per-operative complications
Time Frame
per surgery day 0
Title
post-operative complications
Time Frame
post surgery day 0
Title
measure of quality of life
Description
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.
Time Frame
at month 1
Title
measure of quality of life
Description
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.
Time Frame
at month 6
Title
measure of symptoms improvement
Description
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
Time Frame
at month 1
Title
measure of symptoms improvement
Description
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
Time Frame
at month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Géry LAMBLIN, MD
Phone
472 35 58 71
Ext
+33
Email
gery.lamblin@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie MORET
Email
stephanie.moret@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Géry LAMBLIN, MD
Organizational Affiliation
Hospices Civils de Lyon Gynaecology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Géry LAMBLIN
Phone
4 72 35 58 71
Ext
+33
Email
gery.lamblin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Stéphanie MORET
Email
syephanie.moret@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Géry LAMBLIN, MD
First Name & Middle Initial & Last Name & Degree
Etienne BEAUFILS, MD
First Name & Middle Initial & Last Name & Degree
Philippe CHABERT, MD
First Name & Middle Initial & Last Name & Degree
Gautier CHENE, MD
First Name & Middle Initial & Last Name & Degree
Karine LEBAIL-CARVAL, MD

12. IPD Sharing Statement

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Efficiency of Lina LibrataTM System

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