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

NCT04381416 | Completed

• 1 other identifier: 55P112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cohort I: SEAD treatment

EXPERIMENTAL

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

Cohort II: Repeted SEAD treatment 1m post op

EXPERIMENTAL

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

Interventions

SEAD treatment DEVICE

up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic

Cohort I: SEAD treatment; Cohort II: Repeted SEAD treatment 1m post op

Eligibility Criteria

• Age: 35 Years - 50 Years
• Gender Eligibility Details: premenopausal women suffering from AUB
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocon Medical Ltd.: lead

Study Sites (1)

Sheynovo medical center

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rouemen Velev, Md

  Sheynovo medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 8, 2020
• Study Start: September 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)