IUB SEAD RED (Revolutionary Endometrial Ablation Device Study

PHASE IIB PRE-PIVOTAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF THE IUB SEAD DEVICE IN WOMEN SUFFERING FROM HEAVY MENSTRUAL BLEEDING (HMB)

One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care. This study's focus is on the symptom of HMB which has a number of benign causes.

The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB. The suggested procedure is expected to be simpler than the currently available EA methods and yet should still reduce the need for hysterectomy.

Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, frequency, or regularity is experienced by 10-50% of women of reproductive age, adversely impacts quality of life and can have substantial adverse economic impacts on patients and healthcare systems. One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care. This study's focus is on the symptom of HMB which has a number of benign causes.

While pharmacologic treatment options exist, they are not always effective, and they are frequently associated with both side effects and ongoing cost of care. Consequently, some women desire more definitive options. Endometrial ablation (EA) is a minimally invasive approach designed to manage a number of the causes of HMB and can be performed under direct intrauterine vision with resectoscopic instruments or with a non-resectoscopic approach (non resectoscopic endometrial ablation or NREA). For NREA, one of a number of specially designed device is inserted into the endometrial cavity to deliver thermal, cryogenic or radiofrequency electrical energy in an attempt to destroy the uterine lining or endometrium. In some jurisdictions, NREA has become an accepted office-based procedure, but is still usually performed in an institutional setting, is associated with risks associated with the procedure, anesthesia, and subsequent infertility, and has a failure rate that is averages about 26%. These devices are typically expensive and require training for both the surgeon and the ancillary support staff.

The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB. The suggested procedure is expected to be simpler than the currently available EA methods and yet should still reduce the need for hysterectomy.

Inclusion Criteria:

1. Female subject age 40 to 50 years, inclusive

2. Suffering from the symptom of heavy menstrual bleeding (HMB) from benign causes with no definable organic cause and are candidates for endometrial ablation or surgical treatment.

3. PBAC score of >150 - an average of 2 consecutive screening scores prior to study treatment

4. Are thought to be ovulatory with cyclic predictable onset of menses with a cycle length of 24-38 days.

5. Have either a normal appearing endometrial cavity as assessed by hysteroscopy performed within 90 days of study treatment, or one that is distorted by a FIGO Type 2 submucous leiomyoma ≤3 cm in mean diameter.

6. Have endometrial sampling with normal histology within 6 months of the study procedure.

7. 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

8. Screening hemoglobin levels >9.0 g/dL

9. Uterine sound measurement of 6.5-12 cm (external os to internal fundus)

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

11. women whose sexual activity places them at risk for pregnancy must agree to use an effective, non-hormonal, non-intrauterine method of contraception throughout the course of the study. For this study, acceptable 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]

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

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

14. The subject 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. An endometrial cavity with any of the following: congenital malformation of (eg septate uterus), endometrial polyp >8 mm in largest dimension, FIGO Type 0 or 1 leiomyomas of any diameter or Type 2 leiomyomas > 3 cm in mean diameter; intrauterine adhesions/ synechiae that distort the endometrial cavity sufficient to impair deployment of the SEAD device.
3. Underwent prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural abdominal (laparoscopic or laparotomic) or hysteroscopic myomectomy and/or metroplasty during last 3 months prior to screening, classical Cesarean section, or endometrial ablation
4. Have an abnormal endometrial biopsy that suggests either anovulation or a risk for the development of endometrial cancer (i.e., benign hyperplasia, endometrial hyperplasia with atypia, endometrial intraepithelial neoplasia, endometrial cancer)
5. Have a documented clinical history of titanium allergy or hypersensitivity
6. Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD)
7. Suffers from active infection of the genitals, vagina, cervix, or uterus
8. Presence of bacteremia, sepsis, or other active systemic infection
9. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
10. Known clotting defects or bleeding disorders
11. Currently using anticoagulant treatment
12. 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.
13. Suffers from clinically significant adenomyosis indicated by subject complaints or imaging
14. Presence of an implantable contraceptive device, unless subject agrees to have the device removed immediately on screening, and prior to PBLAC assessment
15. Post-partum ≤ 6-months
16. 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
17. 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.
18. Has a polyp that was not removed before day of treatment
19. Has a BMI>35