Clinical trial: Study to Assess the Safety and Efficacy of the IUB SEAD™ Device (NCT04381416)

Eligibility criteria:
Inclusion Criteria:

          1. Female subject age 35 to 50 years, inclusive

          2. Suffering from heavy menstrual bleeding with no definable organic cause and are
             candidates for global endometrial ablation or surgical treatment

          3. Have a histological finding in a recent (max 4-month-old, with a window of 1 month)
             endometrial biopsy (Pipelle® or other non-treatment-based biopsy) that demonstrates
             benign endometrial histology: proliferative endometrium and/or disordered endometrium
             and/or histological findings associated with dysfunctional endometrium (e.g. irregular
             shading, un-ovulatory bleeding and such); no histological findings of hyperplasia are
             allowed

          4. Premenopausal status confirmed by FSH level measurement at screening (FSH < 40 IU/L).
             FSH level measurement will be repeated in case of a borderline result

          5. Screening hemoglobin levels >9.0 g/dL

          6. Uterine sound measurement of 6.5-11 cm (external os to internal fundus)

          7. PBAC score of >150 for 3 months prior to study treatment or PBAC score >150 one month
             prior to study treatment for women who had at least 3 prior months (documented) of
             failed medical therapy

          8. Predictable, cyclic menstrual cycles

          9. Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment

         10. Sexually active women must agree to use an effective method of contraception
             throughout the course of the study. For this study, effective methods of contraception
             are considered to be those listed below:

               -  Barrier method, i.e., (a) condom (male or female) with spermicide or (b)
                  diaphragm with spermicide or

               -  Vasectomy (partner), or

               -  Abstinence, if in line with the preferred and usual lifestyle of the subject
                  [where abstinence is defined as refraining from heterosexual intercourse]

         11. Subject able to understand and sign a written informed consent form

         12. Subject willing and able to comply with scheduled visits, treatment plan, laboratory
             tests, and other study procedures

         13. Demonstrates an understanding of how to record menstrual blood loss using a menstrual
             pictogram

        Exclusion Criteria:

          1. Pregnant women or those who desire to conceive at any time in the future

          2. Congenital malformation of the uterine cavity (bicornuate, septate)

          3. Inability to visualize the uterine cavity because of intracavitary pathology and/or
             significant uterine asymmetry, including patients with submucous myomas and/or polyps
             and synechiae that heavily distort the uterine cavity

          4. Underwent prior uterine surgery that interrupts the integrity of the uterine wall
             (e.g., transmural myomectomy, classical Cesarean section, endometrial ablation,
             hysteroscopic resection) or a uterine biopsy accompanied by curettage in the last 12
             months

          5. Have abnormal endometrial biopsy (i.e., unresolved adenomatous complex hyperplasia,
             endometrial cancer)

          6. Have a documented clinical history of metal allergy or hypersensitivity

          7. Suffers from active endometritis, active pelvic inflammatory disease (PID) or active
             sexually transmitted disease (STD)

          8. Suffers from active infection of the genitals, vagina, cervix, or uterus

          9. Presence of bacteremia, sepsis, or other active systemic infection

         10. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years

         11. Known clotting defects or bleeding disorders or subjects who went through blood
             transfusion (for any reason) in the three months prior enrollment

         12. Currently using anticoagulant treatment

         13. Subjects with abnormal Papanicolaou (Pap) test or atypical squamous cells of
             undetermined significance (ASCUS) with positive high-risk human papilloma virus (HPV)
             test result within the appropriate screen timeframe, and prior to SEAD™ treatment.
             Alternatively, a colposcopy performed prior to SEAD™ treatment, that showed evidence
             of dysplasia requiring treatment. In case treatment was performed > 6 months prior to
             enrollment and follow-up was done with no evidence of disease by clinical evaluation,
             the subject is eligible.

         14. Previously had endometrial ablation procedure of any kind

         15. Suffers from clinically significant adenomyosis indicated by subject complaints,
             imaging or clinician's judgment

         16. Presence of an implantable contraceptive device

         17. Post-partum ≤ 6-months

         18. Currently participating in or considering participation in a research study of an
             investigational drug or device that would begin during the course of this
             investigational study

         19. Any general health or mental, or other situation or condition which, in the opinion of
             the Investigator, could present an increased risk for the subject or impact the
             subject's ability to comply with protocol requirements.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction