Study to Assess the Safety and Efficacy of the IUB SEAD™ Device

Study Overview
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Brief Summary
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Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in women suffering from abnormal uterine bleeding.

Detailed Description
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Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday activities, can lead to iron deficiency and in severe cases, can necessitate emergency medical care. While pharmacologic treatment options exist, some women desire a treatment that requires less maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied to manage AUB and can be performed using resectoscopic instruments or with a non-resectoscopic approach, in which the device is inserted into the uterine cavity and delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial ablation has become an accepted office-based procedure, but requires training in administration and response to complications of conscious sedation and of assisting personnel. The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is expected to be simpler than the currently available ablation methods and to result in a clinically meaningful delay or abolishment of the need for hysterectomy

Official Title
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Pre-pivotal, Randomized Study to Assess the Safety and Efficacy of the IUB SEAD™ Device in Women Suffering From Abnormal Uterine Bleeding

Conditions
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Abnormal Uterine Bleeding

Intervention / Treatment
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* Device: SEAD treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subject age 35 to 50 years, inclusive Suffering from heavy menstrual bleeding with no definable organic cause and are candidates for global endometrial ablation or surgical treatment 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 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 Screening hemoglobin levels >9.0 g/dL Uterine sound measurement of 6.5-11 cm (external os to internal fundus) 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 Predictable, cyclic menstrual cycles Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment 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] Subject able to understand and sign a written informed consent form Subject willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram Exclusion Criteria: Pregnant women or those who desire to conceive at any time in the future Congenital malformation of the uterine cavity (bicornuate, septate) 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 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 Have abnormal endometrial biopsy (i.e., unresolved adenomatous complex hyperplasia, endometrial cancer) Have a documented clinical history of metal allergy or hypersensitivity Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD) Suffers from active infection of the genitals, vagina, cervix, or uterus Presence of bacteremia, sepsis, or other active systemic infection Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years Known clotting defects or bleeding disorders or subjects who went through blood transfusion (for any reason) in the three months prior enrollment Currently using anticoagulant treatment 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. Previously had endometrial ablation procedure of any kind Suffers from clinically significant adenomyosis indicated by subject complaints, imaging or clinician's judgment Presence of an implantable contraceptive device Post-partum ≤ 6-months 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 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort I: SEAD treatment<br>Following the first SEAD™ treatment, women who experience a sub-optimal treatment response (at least 3 months after the first treatment) will be eligible to receive a second SEAD™ treatment (see re-treatment criteria below), which will be performed during the first 1-3 days following the cessation of their menses immediately following decision to retreat. | Device: SEAD treatment<br>* up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic<br>|
| Experimental: Cohort II: Repeted SEAD treatment 1m post op<br>Following the first SEAD™ treatment, women will undergo a second SEAD™ treatment during the first 1-3 days following the cessation of their next menses. | Device: SEAD treatment<br>* up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | assess the 12-month safety of IUB SEAD treatment in women suffering from AUB. | 12 months | 
| Pictorial Blood Loss Assessment Chart changes from baseline | To assess the efficacy of IUB SEAD treatment in women suffering from AUB, 12 months after treatment. | 12 months |