Phase IIb Pre-pivotal Study to Assess the Safety and Efficacy of the IUB SEAD™ Device in Women Suffering From Heavy Menstrual Bleeding (HMB) (HMB)

  • STATUS
    Recruiting
  • End date
    Jul 21, 2023
  • participants needed
    30
  • sponsor
    Ocon Medical Ltd.
Updated on 21 October 2022
vasectomy
hysterectomy
serum pregnancy test
cavity
follicle stimulating hormone
endometrial ablation
fibroids
hysteroscopy
iron deficiency
sound measurement

Summary

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.

Description

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.

Details
Condition Heavy Menstrual Bleeding
Treatment IUB SEAD
Clinical Study IdentifierNCT04959396
SponsorOcon Medical Ltd.
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female subject age 40 to 50 years, inclusive
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
PBAC score of >150 - an average of 2 consecutive screening scores prior to study treatment
Are thought to be ovulatory with cyclic predictable onset of menses with a cycle length of 24-38 days
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
Have endometrial sampling with normal histology within 6 months of the study procedure
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 6.5-12 cm (external os to internal fundus)
Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment
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]
Subject is able to understand and sign a written informed consent form
Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
The subject 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
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
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
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)
Have a documented clinical history of titanium 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
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
Suffers from clinically significant adenomyosis indicated by subject complaints or imaging
Presence of an implantable contraceptive device, unless subject agrees to have the device removed immediately on screening, and prior to PBLAC assessment
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
Has a polyp that was not removed before day of treatment
Has a BMI>35
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