Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss in Sites Across the United Kingdom

Not Applicable

• Conditions: Heavy Menstrual Bleeding
• Interventions: Device: Librata Endometrial Ablation

• Registration Number: NCT02971189
• Lead Sponsor: Birmingham Women's NHS Foundation Trust

Brief 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.

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:

1. Rates of bleeding at months 3, 6 and 12 as measured by menstrual pictogram

2. Rate of serious adverse device effects through to day 30 post-operatively

3. Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy at 6 and 12 months

4. Rates of patient satisfaction at 6 and 12 months.

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-19
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-22
• Last Update Posted: 2016-11-22
• Study Start: 2016-12
• Primary Completion: 2017-01
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Refractory heavy menstrual bleeding with no definable organic cause

2. Female subject from (and including) age 25 to 50 years

3. Uterine sound measurement between 6.0 to 10.0cm (external os to fundus).

4. 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:

     • at least 3 prior months documented failed medical therapy; or
     • a contraindication to medical therapy; or
     • refused medical therapy

5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L

6. Not pregnant and no desire to conceive at any time

7. 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.

8. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC

9. Subject agrees to follow-up schedule and data collection requirements

10. Subject is literate or demonstrates an understanding on how to collect menstrual blood loss products, and use of the Menstrual Pictogram (MP) diary

Exclusion Criteria

Participants who have or meet any of the following exclusion criteria will not be enrolled in the Study:

1. Pregnancy or subject with a desire to become pregnant

2. Endometrial hyperplasia as confirmed by histology

3. Presence of active endometritis

4. Active pelvic inflammatory disease

5. Active sexually transmitted disease (STD), at the time of ablation.

   • Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.

6. Presence of bacteraemia, sepsis, or other active systemic infection

7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure

8. Known/suspected gynecological malignancy within the past 5 years

9. Known clotting defects or bleeding disorders

10. Untreated/unevaluated cervical dyskaryosis (except CIN I)

11. Known or suspected abdominal/pelvic cancer

12. Prior uterine surgery (except lower segment caesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)

13. Previous endometrial ablation procedure

14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)

15. Currently on anticoagulants

16. 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

17. Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit

18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).

19. Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation.

20. Subject wanting concomitant hysteroscopic sterilization.

21. Subject who is within 6-weeks post-partum.

22. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject

23. Any subject who is currently participating or considers future participation in any other

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Librata endometrial ablation	Librata Endometrial Ablation	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.

Primary Outcome Measures

Name	Time	Method
Procedure success defined as device success (completion of treatment cycles according to device specifications) and no occurence of intra-procedural complications.	Day of surgery

Secondary Outcome Measures

Name	Time	Method
rates of bleeding as measured by menstrual pictogram	12 months
rate of serious adverse device effects	day 30 post-operatively
Rates of re-intervention for menstrual related bleeding or pain and/or hysterectomy	12 months
Rates of patient satisfaction	12 months