IUB SEAD RED (Revolutionary Endometrial Ablation Device Study

NCT04959396 | Unknown DMC

• 1 other identifier: 55P140
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence and characteristics of device and/or procedure related adverse events

  Incidence and characteristics of device and/or procedure related adverse events (AEs) occurring during the 6-months following SEAD™ device treatment

  6 months

• Efficacy: Reduction in bleeding volume as measured by Pictorial Blood Loss Assessment Chart (PBAC) at 6 months post-treatment compared to baseline

  Change in bleeding volume as measured by Pictorial Blood Loss Assessment Chart (PBAC) at 6 months post-treatment compared to baseline

  6 months

Secondary Outcomes (2)

• 1. Change from baseline quality of life (QoL) scores, as assessed using the MIQ questionnaire at 6, 12, 24 and 36 months post-treatment.

  36 months

• Bleeding volume

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

IUB SEAD procedure

Device: IUB SEAD

Interventions

IUB SEAD DEVICE

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

Treatment

Eligibility Criteria

• Age: 40 Years - 50 Years
• Gender Eligibility Details: Gender having a uterus
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocon Medical Ltd.: lead

Study Sites (9)

Imedi Clinic

Tbilisi, Georgia

ACTIVE NOT RECRUITING

In Vitro Clinic - Leadermed

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Medinvest

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Zurab Sabakhtarashvili Reproductive Clinic

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Barzilai MC

Ashkelon, Israel

ACTIVE NOT RECRUITING

Soroka MC

Beersheba, Israel

RECRUITING

Shamir medical center

Rishon LeZiyyon, Israel

NOT YET RECRUITING

Ziv medical center

Safed, Israel

RECRUITING

Tzafon MC (Poriya Baruch Padeh)

Tiberias, Israel

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Menorrhagia

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; Menstruation Disturbances

Study Officials

• Oshri Barel, Md

  Assuta Ashdod

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oshri Barel, Md

CONTACT

08-3004100; oshrib@assuta.co.il

Sergio Haimovich, Md

CONTACT

072-215-0105; sergio@oconmed.com

Study Design

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

Model Details: Endometrium ablation with the IUB SEAD device

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 13, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (4); IL (5)