MenorrhagiaTHERMOLIBNCT03670680
Efficiency of Lina LibrataTM System
A study testing Use of the Lina LibrataTM in people with Menorrhagia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 38 to 55 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Use of the Lina LibrataTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women from 40 to 50 years old
- Not menopausal women
- Do not want pregnancy
- Having dysfunctional bleeding
- informed and signed consent
Who cannot join
- 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
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- Pelvic inflammation
- Inability to understand information provided
- Not covered by a national health insurance scheme, prisoner or under administrative supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Menorrhagia
- Being tested
- Use of the Lina LibrataTM
- Keywords
- Menorrhagia, Lina LibrataTM, efficiency, menometrorrhagia
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Lina LibrataTMDevice
Use of the Lina LibrataTM
| Study group | Role | What they receive |
|---|---|---|
| Lina LibrataTM | Experimental | Use of the Lina LibrataTM Receives: Device: Use of the Lina LibrataTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of amenorrhea
Measured: 4 weeks
Secondary outcomes (22)
pain score
Pain at Hour 0 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Measured: during surgery (Hour 0)
pain score
Pain at Hour 2 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Measured: 2 hours after surgery (Hour 2)
pain score
Pain at Hour 6 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
Measured: 6 hours after surgery (Hour 6)
pain score
Pain at Hour 6 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain)..
Measured: 6 hours after surgery (Hour 6)
pain score
Pain at Day 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine).
Measured: the day after surgery (Day 1)
pain score
Pain at Day 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Measured: the day after surgery (Day 1)
pain score
Pain at Day 7 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
Measured: one week after surgery (Day 7)
pain score
Pain at Day 7 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Measured: one week after surgery (Day 7)
pain score
Pain at Month 1 is assessed by QDSA (Questionnaire de la Douleur Saint-Antoine)
Measured: one month after surgery (Month 1)
pain score
Pain at Month 1 is assessed by VAS (Visual Analog Scale) rating from 0 to 10 (0=no pain).
Measured: one month after surgery (Month 1)
recurrences of menorrhagia
Measured: at month 1
recurrences of menorrhagia
Measured: at month 6
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.
Measured: 1 month after surgery
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.
Measured: 6 months after surgery
evolution of hemoglobinemia
hemoglobin measured by blood test
Measured: 1 month after surgery
evolution of hemoglobinemia
hemoglobin measured by blood test
Measured: 6 months after surgery
per-operative complications
Measured: per surgery day 0
post-operative complications
Measured: post surgery day 0
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.
Measured: at month 1
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.
Measured: at month 6
measure of symptoms improvement
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
Measured: at month 1
measure of symptoms improvement
assessed by the questionnaire PGI-I (from 1 "much better" to 7 "much worse")
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start16 Oct 2018
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géry LAMBLIN, MD, Principal investigator, Hospices Civils de Lyon Gynaecology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670680
- Sponsor's protocol ID
- 69HCL17_0266
- Other IDs
- 2017-A02017-46
- Acronym
- THERMOLIB
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2018
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia
- ClinicalTrials.gov ID
- NCT03670680
- Acronym / sponsor ID
- THERMOLIB / 69HCL17_0266
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia, Lina LibrataTM, efficiency, menometrorrhagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lina LibrataTM | Experimental | Device: Use of the Lina LibrataTMUse of the Lina LibrataTM |
Who may qualify
- Ages
- 38 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women from 40 to 50 years old
- Not menopausal women
- Do not want pregnancy
- Having dysfunctional bleeding
- informed and signed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the Lina LibrataTMUse of the Lina LibrataTM | Device | Lina LibrataTM |
Primary outcome
rate of amenorrhea
Time frame: 4 weeks
22 secondary outcomes
pain score
Time frame: during surgery (Hour 0)
pain score
Time frame: 2 hours after surgery (Hour 2)
pain score
Time frame: 6 hours after surgery (Hour 6)
pain score
Time frame: 6 hours after surgery (Hour 6)
pain score
Time frame: the day after surgery (Day 1)
pain score
Time frame: the day after surgery (Day 1)
pain score
Time frame: one week after surgery (Day 7)
pain score
Time frame: one week after surgery (Day 7)
pain score
Time frame: one month after surgery (Month 1)
pain score
Time frame: one month after surgery (Month 1)
recurrences of menorrhagia
Time frame: at month 1
recurrences of menorrhagia
Time frame: at month 6
assessment of menorrhagia on Higham's score
Time frame: 1 month after surgery
assessment of menorrhagia on Higham's score
Time frame: 6 months after surgery
evolution of hemoglobinemia
Time frame: 1 month after surgery
evolution of hemoglobinemia
Time frame: 6 months after surgery
per-operative complications
Time frame: per surgery day 0
post-operative complications
Time frame: post surgery day 0
measure of quality of life
Time frame: at month 1
measure of quality of life
Time frame: at month 6
measure of symptoms improvement
Time frame: at month 1
measure of symptoms improvement
Time frame: at month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Géry LAMBLIN, MD principal investigator
Hospices Civils de Lyon Gynaecology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Lina LibrataTM in people with Menorrhagia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of amenorrhea (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.