Clinical trial: Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (NCT04267562)

Eligibility criteria:
Key Inclusion Criteria: Qualified participants must meet all of the following inclusion
        criteria.

          1. Female age 30 to 50 years

          2. Excessive menstrual bleeding due to benign causes

          3. Uterine sounding depth measurement of 6.0 - 12.0 cm

          4. A minimum uterine cavity length of 4.0 cm

          5. A minimum PBLAC score of ≥ 150 for 1 menstrual cycle (obtained during screening) and
             must also have a documented history of excessive menstrual bleeding prior to study
             enrollment

          6. Endometrial biopsy within 12 months prior to treatment procedure with no abnormal
             pathology

          7. Premenopausal at screening as determined by FSH measurement ≤ 40 IU/L when age is ≥ 40
             years

          8. Patient agrees to use a reliable form of contraception during the study and to follow
             these requirements: (a) If a hormonal birth control method is used for contraception,
             the patient must have been on said method for ≥ 3 months prior to the onset of the
             screening menstrual cycle and agrees to remain on the same hormonal regimen through
             the initial 12-month post-treatment follow-up (pills, injections, patches, rings,
             implants); (b) Patient also agrees to not use hormonal birth control during the first
             12-month post-treatment follow-up period if they were not using hormonal birth control
             during the 3 months prior to treatment

          9. Ability to provide written informed consent

         10. Patient is literate and clearly demonstrates understanding on how to use PBLAC after
             training

         11. Patient agrees to the following during the study: (a) No initiation of hormonal
             contraception or any other medical intervention for bleeding; (b) Attend all follow-up
             exams through the 36-month follow-up timepoint; and (c) Exclusive use of
             study-provided sanitary products and submission of completed PBLAC diaries through the
             12-month post-treatment follow-up

        Key Exclusion Criteria: Qualified participants must NOT meet any of the following exclusion
        criteria.

          1. Pregnant, or desires to retain fertility

          2. Current or documented history of endometrial hyperplasia

          3. Active endometritis

          4. Clinically significant or suspected adenomyosis indicated by patient complaints,
             imaging, or clinician's judgment

          5. Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract

          6. Active pelvic inflammatory disease

          7. Currently using an intrauterine device (IUD), including Mirena™ device, and unwilling
             to remove the IUD

          8. Presence of an implantable contraceptive device (e.g., Essure®) protruding into the
             uterine cavity

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

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

         11. Currently on anticoagulants

         12. Known clotting defects or bleeding disorders

         13. Currently on medications that could thin the myometrium, such as long-term steroid use

         14. Previous medical/surgical treatments, or has other conditions, that could lead to
             anatomic/pathologic weakness or thinning of the myometrium

         15. Any general health, mental health or social situation which, in the opinion of the
             investigator, could represent an increased risk for the patient, or the ability of the
             patient to complete study requirements

         16. Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis

         17. Abdominal, pelvic or gynecological malignancy

         18. Untreated/unevaluated cervical dysplasia, except cervical intrepithelial neoplasia I
             (CIN I)

         19. Previous endometrial ablation procedure

         20. Abnormal or obstructed, or perforated cavity as determined by investigator via
             standard clinical practices (e.g., hysteroscopy, saline infusion sonohysterography).

         21. Intramural or subserosal myomas > 3 cm in size, or any myoma that distorts the uterine
             cavity

         22. Any patient who is currently participating or considering participation in any other
             research of an investigational drug or device
Female
Accepts Healthy Volunteers
Subject must be at least 30 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? Contradiction