Heavy Menstrual Bleeding
Conditions
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.
Interventions
DEVICELibrata Endometrial Ablation
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.
Sponsors
Birmingham Women's NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactJustin Clark, MB ChB, MD
Backup ContactHelen Stevenson, MB ChB
Outcome results
None listed