Heavy Menstrual BleedingHMBNCT05606146
IUB SEAD RED (Revolutionary Endometrial Ablation Device Study)
A study testing IUB SEAD in people with Heavy Menstrual Bleeding, run by Ocon Medical Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- IUB SEAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Feb 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 to any component of IUB™SEAD™.
- Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD)
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shamir medical center
Rishon LeZiyyon
Noam Smorjick, MD
About this study
Official title: Phase IIc (Protocol 55P127): Addition of up to 10 Women to Explore Silver Systemic Absorption as a Continuation Study to: Phase IIb (Protocol 55P140)
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 a hysterectomy.
Read the 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 averages about 26%. These devices are typically expensive and require training for 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 a hysterectomy. This study will evaluate an additional exploratory endpoint in order to evaluate if there are detectable levels of silver in blood following SEAD treatment. SEAD treatment is performed locally by intrauterine administration for a duration of 30 minutes, during which the silver nitrate beads gradually dissolve. Upon dissolution the silver ions act on the mucus layer of the endometrium by binding to proteins and causing their denaturation, resulting in the formation of an eschar. The effect is local, and the bound silver is no longer active therefore it is unlikely that 100% of the silver dose will be available for absorption.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- IUB SEAD
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUB SEADDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | IUB SEAD procedure Receives: Device: IUB SEAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and characteristics of device and/or procedure related adverse events (AEs)
occurring during the 6-months following SEAD™ device treatment
Measured: 6 months
Efficacy: Change in bleeding volume
measured by Pictorial Blood Loss Assessment Chart (PBAC) at 6 months post-treatment compared to baseline.
Measured: 6 months
Secondary outcomes (2)
Change from baseline quality of life (QoL)
as assessed using the MIQ questionnaire at 6, 12, 24- and 36-months post-treatment.
Measured: 36 months
Change in bleeding volume
measured by Pictorial Blood Loss Assessment Chart (PBAC) at 12, 24- and 36-months post treatment.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start23 Feb 2023
- Primary completionMar 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endometrium ablation with the IUB SEAD device
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocon Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noam Smorjick, MD, Principal investigator, Shamir medical center ,Rishon LeZion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606146
- Sponsor's protocol ID
- 55P127
- Acronym
- HMB
- Status last verified
- Nov 2023
- First submitted
- 24 Oct 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIc (Protocol 55P127): Addition of up to 10 Women to Explore Silver Systemic Absorption as a Continuation Study to: Phase IIb (Protocol 55P140)
- ClinicalTrials.gov ID
- NCT05606146
- Acronym / sponsor ID
- HMB / 55P127
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ocon Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 a 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 averages about 26%. These devices are typically expensive and require training for 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 a hysterectomy. This study will evaluate an additional exploratory endpoint in order to evaluate if there are detectable levels of silver in blood following SEAD treatment. SEAD treatment is performed locally by intrauterine administration for a duration of 30 minutes, during which the silver nitrate beads gradually dissolve. Upon dissolution the silver ions act on the mucus layer of the endometrium by binding to proteins and causing their denaturation, resulting in the formation of an eschar. The effect is local, and the bound silver is no longer active therefore it is unlikely that 100% of the silver dose will be available for absorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endometrium ablation with the IUB SEAD device
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: IUB SEADIUB SEAD procedure |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (18 listed)
- 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 to any component of IUB™SEAD™.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUB SEADThe 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 | Device | Treatment |
Primary outcome
Safety: Incidence and characteristics of device and/or procedure related adverse events (AEs)
Time frame: 6 months
occurring during the 6-months following SEAD™ device treatment
Efficacy: Change in bleeding volume
Time frame: 6 months
measured by Pictorial Blood Loss Assessment Chart (PBAC) at 6 months post-treatment compared to baseline.
2 secondary outcomes
Change from baseline quality of life (QoL)
Time frame: 36 months
Change in bleeding volume
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noam Smorjick, MD principal investigator
Shamir medical center ,Rishon LeZion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUB SEAD in people with Heavy Menstrual Bleeding, run by Ocon Medical Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noam Smorjick, MD (089772512, nsmorgik@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and characteristics of device and/or procedure related adverse events (AEs) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.