- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670680
Efficiency of Lina LibrataTM System (THERMOLIB)
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Géry LAMBLIN, MD
- Phone Number: +33 472 35 58 71
- Email: gery.lamblin@chu-lyon.fr
Study Contact Backup
- Name: Stéphanie MORET
- Email: stephanie.moret@chu-lyon.fr
Study Locations
-
-
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Bron, France, 69500
- Recruiting
- Hospices Civils de Lyon
-
Principal Investigator:
- Géry LAMBLIN, MD
-
Sub-Investigator:
- Gautier CHENE, MD
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Sub-Investigator:
- Philippe CHABERT, MD
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Sub-Investigator:
- Karine LEBAIL-CARVAL, MD
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Contact:
- Géry LAMBLIN
- Phone Number: +33 4 72 35 58 71
- Email: gery.lamblin@chu-lyon.fr
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Contact:
- Stéphanie MORET
- Email: syephanie.moret@chu-lyon.fr
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Sub-Investigator:
- Etienne BEAUFILS, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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)..
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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
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at month 1
|
|
recurrences of menorrhagia
Time Frame: at month 6
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at month 6
|
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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
Sponsor
Investigators
- Principal Investigator: Géry LAMBLIN, MD, Hospices Civils de Lyon Gynaecology Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0266
- 2017-A02017-46 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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