Uterine LeiomyomaEMBOSOFT INCT03535610
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
A study testing Uterine Embolization in people with Uterine Leiomyoma, run by Scitech Produtos Medicos SA at 1 site in Brazil.
Trial summary
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Leiomyoma
- What is being tested?
- Uterine Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Aug 2018to 20 May 2020
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients from 18 to 50 years old;
- symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
- patient agrees with study procedures;
- patient signs the informed consent form.
Who cannot join
- asymptomatic women;
- isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
- leiomyoma diameter higher than 10 cm;
- leiomyoma above the umbilical scar;
- endometrial neoplasia or hyperplasia or presence of any malignancy
- pregnant or breast feeding women;
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- active vasculitis;
- pelvic irradiation history;
- uncontrolled coagulopathies;
- renal insufficiency;
- contrast allergy;
- concomitant use of GnRH analogues.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Certa Centro de Referência em Tratamentos Avançados
São Paulo, São Paulo, 01401-002
About this study
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
- Conditions
- Uterine Leiomyoma
- Being tested
- Uterine Embolization
- Keywords
- Embolization, Uterine Leiomyoma, Embospheres, Microspheres
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine EmbolizationDevice
Uterine Embolization with PVA Microspheres
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | Uterine Embolization with PVA Microspheres Receives: Device: Uterine Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Volume Reduction
Uterine Volume Reduction measured by MRI
Measured: 6 months
Fibroid Reduction
Fibroid Reduction measured by MRI
Measured: 6 months
Secondary outcomes (2)
Quality of Life Improvement
Quality of Life Improvement measured by UFS-QOL
Measured: 6 months
Ovarian Function
Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start13 Aug 2018
- Primary completion20 Feb 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomaStudies 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
- Prospective, single-arm, open label study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535610
- Sponsor's protocol ID
- SC-ES_001
- Acronym
- EMBOSOFT I
- Status last verified
- Sep 2020
- First submitted
- 14 May 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
- ClinicalTrials.gov ID
- NCT03535610
- Acronym / sponsor ID
- EMBOSOFT I / SC-ES_001
- Conditions
- Uterine Leiomyoma
- Keywords
- Embolization, Uterine Leiomyoma, Embospheres, Microspheres
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 24 May 2018 (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.
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, open label study
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Device: Uterine EmbolizationUterine Embolization with PVA Microspheres |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- female patients from 18 to 50 years old;
- symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
- patient agrees with study procedures;
- patient signs the informed consent form.
Key exclusion criteria (12 listed)
- asymptomatic women;
- isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
- leiomyoma diameter higher than 10 cm;
- leiomyoma above the umbilical scar;
- endometrial neoplasia or hyperplasia or presence of any malignancy
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 |
|---|---|---|
| Uterine EmbolizationUterine Embolization with PVA Microspheres | Device | Embolization |
Primary outcome
Uterine Volume Reduction
Time frame: 6 months
Uterine Volume Reduction measured by MRI
Fibroid Reduction
Time frame: 6 months
Fibroid Reduction measured by MRI
2 secondary outcomes
Quality of Life Improvement
Time frame: 6 months
Ovarian Function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Embolization in people with Uterine Leiomyoma, run by Scitech Produtos Medicos SA at 1 site in Brazil.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 4 Sep 2020. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Volume Reduction (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 4 Sep 2020.