Clinical trial: Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss (NCT03725306)

Eligibility criteria:
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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? 0