Heavy Menstrual BleedingLEADERUKNCT02971189
Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom
A study testing Librata Endometrial Ablation in people with Heavy Menstrual Bleeding, run by Birmingham Women's NHS Foundation Trust.
Trial summary
A prospective, single-arm, non-randomised study to evaluate the Librata device performance and acute safety in performing global endometrial ablation in pre-menopausal women with heavy menstrual bleeding. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Librata Endometrial Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Aug 2017
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Refractory heavy menstrual bleeding with no definable organic cause
- Female subject from (and including) age 25 to 50 years
- Uterine sound measurement between 6.0 to 10.0cm (external os to fundus).
- A minimum menstrual blood loss of
- Menstrual Pictogram (MP) score of ≥150 for 3 consecutive months prior to study enrollment; OR,
- MP score ≥150 for one month for women who either had:
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- at least 3 prior months documented failed medical therapy; or
- a contraindication to medical therapy; or
- refused medical therapy
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
- Not pregnant and no desire to conceive at any time
- Subject agrees to use a reliable form of contraception. If a hormonal birth control method is used, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through their study participation.
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- Subject agrees to follow-up schedule and data collection requirements
- Subject is literate or demonstrates an understanding on how to collect menstrual blood loss products, and use of the Menstrual Pictogram (MP) diary
Who cannot join
- Participants who have or meet any of the following exclusion criteria will not be enrolled in the Study:
- Pregnancy or subject with a desire to become pregnant
- Endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD), at the time of ablation.
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- Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.
- Presence of bacteraemia, sepsis, or other active systemic infection
- Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- Known/suspected gynecological malignancy within the past 5 years
- Known clotting defects or bleeding disorders
- Untreated/unevaluated cervical dyskaryosis (except CIN I)
- Known or suspected abdominal/pelvic cancer
- Prior uterine surgery (except lower segment caesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
- Previous endometrial ablation procedure
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
- Currently on anticoagulants
- Abnormal shaped uterine cavity as confirmed by transvaginal ultrasound scan +/- hysteroscopy - specifically:
- Septate or bicornuate uterus or other congenital malformation of the uterine cavity
- Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity
- Polyps > 2cm in maximum diameter
- Intramural or subserosal fibroid greater than 3 cm
- Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit
- Presence of an implantable contraceptive device (e.g. Essure or Adiana).
- Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation.
- Subject wanting concomitant hysteroscopic sterilization.
- Subject who is within 6-weeks post-partum.
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
- Any subject who is currently participating or considers future participation in any other
Trial locations and contacts
No sites are listed yet.
About this study
A prospective, single-arm, non-randomised study to evaluate the Librata device performance and acute safety in performing global endometrial ablation in pre-menopausal women with heavy menstrual bleeding.
Read the detailed description
4 clinical sits around the UK aim to recruit 40 women into a study to assess the primary objective of procedure success using the Librata endometrial ablation device, as defined as device success (completion of treatment cycles according to device specifications) and no occurrence of intra-procedural complications.
The investigators will also assess the secondary objectives of:
- Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram
- Rate of serious adverse device effects through to day 30 post-operatively
- Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6 and 12 months
- Rates of patient satisfaction at 6 and 12 months.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Librata Endometrial Ablation
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Librata Endometrial AblationDevice
The treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Librata endometrial ablation | Other | Librata thermal balloon endometrial ablation treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events. Receives: Device: Librata Endometrial Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.
Measured: Day of surgery
Secondary outcomes (4)
rates of bleeding as measured by menstrual pictogram
Measured: 12 months
rate of serious adverse device effects
Measured: day 30 post-operatively
Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy
Measured: 12 months
Rates of patient satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mr.Justin Clark, Birmingham Women's NHS Foundation Trust
- Investigators
- Justin Clark, MB ChB, MD, Principal investigator, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971189
- Sponsor's protocol ID
- Birmingham WHC
- Acronym
- LEADERUK
- Status last verified
- Nov 2016
- First submitted
- 19 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Shaw RW, Brickley MR, Evans L, Edwards MJ. Perceptions of women on the impact of menorrhagia on their health using multi-attribute utility assessment. Br J Obstet Gynaecol. 1998 Nov;105(11):1155-9. doi: 10.1111/j.1471-0528.1998.tb09968.x.
PubMed 9853763
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom
- ClinicalTrials.gov ID
- NCT02971189
- Acronym / sponsor ID
- LEADERUK / Birmingham WHC
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- Dec 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- 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.
A prospective, single-arm, non-randomised study to evaluate the Librata device performance and acute safety in performing global endometrial ablation in pre-menopausal women with heavy menstrual bleeding.
Detailed description
4 clinical sits around the UK aim to recruit 40 women into a study to assess the primary objective of procedure success using the Librata endometrial ablation device, as defined as device success (completion of treatment cycles according to device specifications) and no occurrence of intra-procedural complications.
The investigators will also assess the secondary objectives of:
- Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram
- Rate of serious adverse device effects through to day 30 post-operatively
- Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6 and 12 months
- Rates of patient satisfaction at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Librata endometrial ablation | Other | Device: Librata Endometrial AblationLibrata thermal balloon endometrial ablation treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Refractory heavy menstrual bleeding with no definable organic cause
- Female subject from (and including) age 25 to 50 years
- Uterine sound measurement between 6.0 to 10.0cm (external os to fundus).
- A minimum menstrual blood loss of
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
Key exclusion criteria (29 listed)
- Participants who have or meet any of the following exclusion criteria will not be enrolled in the Study:
- Pregnancy or subject with a desire to become pregnant
- Endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
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 |
|---|---|---|
| Librata Endometrial AblationThe treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events. | Device | Librata endometrial ablation |
Primary outcome
Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.
Time frame: Day of surgery
4 secondary outcomes
rates of bleeding as measured by menstrual pictogram
Time frame: 12 months
rate of serious adverse device effects
Time frame: day 30 post-operatively
Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy
Time frame: 12 months
Rates of patient satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Background: PubMed 9853763Shaw RW, Brickley MR, Evans L, Edwards MJ. Perceptions of women on the impact of menorrhagia on their health using multi-attribute utility assessment. Br J Obstet Gynaecol. 1998 Nov;105(11):1155-9. doi: 10.1111/j.1471-0528.1998.tb09968.x.
- link to pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Justin Clark, MB ChB, MD principal investigator
Birmingham Women's NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Librata Endometrial Ablation in people with Heavy Menstrual Bleeding, run by Birmingham Women's NHS Foundation Trust.
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 15 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Clark, MB ChB, MD (0044 1216074712, t.j.clark@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications. (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971189, which also lists 1 linked publication.
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 Nov 2016.