Menorrhagia Clinical Trial
— LEADEROfficial title:
Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss
Verified date | November 2018 |
Source | LiNA Medical |
Contact | Barbara Cox |
Phone | 6175964183 |
bco[@]lina-medical.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the safety and effectiveness of the endometrial ablation device Librata in reducing menstrual blood loss at 12 months post-treatment when used in pre‑menopausal women with menorrhagia due to benign causes for whom childbearing is complete.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 50 Years |
Eligibility |
Candidates for this study must meet ALL of the following criteria: - Refractory menorrhagia with no organic cause - Female subject from (and including) age 25 to 50 years - Uterine sound measurement =6.0 cm to = 10.0cm (external os to fundus). - A minimum menstrual blood loss - for subjects not using medical therapy, a Menstrual Pictogram(MP) score of =150 for two baseline cycles within three months prior to treatment OR - MP score =150 for one month for women who either had - at least 3 prior months documented failed medical therapy; or - had 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 visits and data collection requirements - Subject who is literate or demonstrates an understanding on how to use the Menstrual Pictogram (MP) diary 4.1.1. EXCLUSION CRITERIA To be enrolled, candidates should NOT meet any exclusion criterion: - 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. o Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment. - Presence of bacteremia, 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 dysplasia (except CIN I) - Known/suspected abdominal/pelvic cancer - Prior uterine surgery (except low segment cesarean 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 or obstructed cavity as confirmed by transvaginal ultrasound +/- hysteroscopy - specifically: 1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity 2. Submucosal fibroids (grade 0-2) which protrude >1cm into the uterine cavity 3. Polyps >2 cm in maximum diameter 4. Any intramural myoma > 3 cm or which distorts the uterine cavity - Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit - Presence of an implanted 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 in the primary endpoint phase of an on-going investigational drug or device study or intends future participation in any other research of an investigational drug or device during the primary endpoint phase of this study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
LiNA Medical | Infinite Clinical Research, S.A. de C.V., Syntactx, West Virginia University, Pathology Laboratory for Translational Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Menstrual Bleeding | Clinical success defined as a reduction of menstrual bleeding, defined as a score of 75 or less or 50% reduction from baseline on the Menstrual Pictogram scoring diary. | 12 months post-treatment | |
Primary | Incidence of serious adverse events (SAEs). | The primary safety endpoint | 12 months post-treatment | |
Secondary | Changes in Quality of Life | Responses from quality of life questionnaires | 12 months | |
Secondary | Procedure Time | Librata ablation procedure time | During procedure | |
Secondary | Menstrual Blood Loss | Menstrual blood loss assessment | 3, 6, 12, 24 and 36 months | |
Secondary | Rates of Re-Intervention | Rate of repeat ablation and/or hysterectomy surgery | Month 12 | |
Secondary | Incidence of Unanticipated Adverse Device Effects (UADEs) | Month 12 |
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