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IUB SEAD RED (Revolutionary Endometrial Ablation Device Study (HMB)

Primary Purpose

Heavy Menstrual Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IUB SEAD
Sponsored by
Ocon Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female subject age 40 to 50 years, inclusive
  2. 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.
  3. PBAC score of >150 - an average of 2 consecutive screening scores prior to study treatment
  4. Are thought to be ovulatory with cyclic predictable onset of menses with a cycle length of 24-38 days.
  5. 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.
  6. Have endometrial sampling with normal histology within 6 months of the study procedure.
  7. 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
  8. Screening hemoglobin levels >9.0 g/dL
  9. Uterine sound measurement of 6.5-12 cm (external os to internal fundus)
  10. Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment
  11. 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]
  12. Subject is able to understand and sign a written informed consent form
  13. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  14. The subject 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. 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.
  3. 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
  4. 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)
  5. Have a documented clinical history of titanium allergy or hypersensitivity
  6. Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD)
  7. Suffers from active infection of the genitals, vagina, cervix, or uterus
  8. Presence of bacteremia, sepsis, or other active systemic infection
  9. Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
  10. Known clotting defects or bleeding disorders
  11. Currently using anticoagulant treatment
  12. 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.
  13. Suffers from clinically significant adenomyosis indicated by subject complaints or imaging
  14. Presence of an implantable contraceptive device, unless subject agrees to have the device removed immediately on screening, and prior to PBLAC assessment
  15. Post-partum ≤ 6-months
  16. 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
  17. 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.
  18. Has a polyp that was not removed before day of treatment
  19. Has a BMI>35

Sites / Locations

  • Shamir medical center
  • Ziv medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

IUB SEAD procedure

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2021
Last Updated
October 24, 2022
Sponsor
Ocon Medical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04959396
Brief Title
IUB SEAD RED (Revolutionary Endometrial Ablation Device Study
Acronym
HMB
Official Title
PHASE IIB PRE-PIVOTAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF THE IUB SEAD DEVICE IN WOMEN SUFFERING FROM HEAVY MENSTRUAL BLEEDING (HMB)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocon Medical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Endometrium ablation with the IUB SEAD device
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
IUB SEAD procedure
Intervention Type
Device
Intervention Name(s)
IUB SEAD
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety: Incidence and characteristics of device and/or procedure related adverse events
Description
Incidence and characteristics of device and/or procedure related adverse events (AEs) occurring during the 6-months following SEAD™ device treatment
Time Frame
6 months
Title
Efficacy: Reduction in bleeding volume as measured by Pictorial Blood Loss Assessment Chart (PBAC) at 6 months post-treatment compared to baseline
Description
Change in bleeding volume as measured by Pictorial Blood Loss Assessment Chart (PBAC) at 6 months post-treatment compared to baseline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
1. Change from baseline quality of life (QoL) scores, as assessed using the MIQ questionnaire at 6, 12, 24 and 36 months post-treatment.
Description
Change from baseline quality of life (QoL) scores
Time Frame
36 months
Title
Bleeding volume
Description
Reduction in bleeding volume
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender having a uterus
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oshri Barel, Md
Phone
08-3004100
Email
oshrib@assuta.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Haimovich, Md
Phone
072-215-0105
Email
sergio@oconmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oshri Barel, Md
Organizational Affiliation
Assuta Ashdod
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shamir medical center
City
Rishon LeZion
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noam Smorjick, MD
Facility Name
Ziv medical center
City
Safed
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inbar Ben Shachar, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IUB SEAD RED (Revolutionary Endometrial Ablation Device Study

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