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

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

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

Study Overview

• Status: Completed
• Conditions: Abnormal Uterine Bleeding
• Intervention / Treatment: Device: SEAD treatment

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Sheynovo medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort I: SEAD treatment; 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; up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic
Experimental: Cohort II: Repeted SEAD treatment 1m post op; 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; up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ocon Medical Ltd.
• Investigators: Principal Investigator: Rouemen Velev, Md, Sheynovo medical center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: 55P112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No