An interventional study of Uterine Embolization in Uterine Leiomyoma, sponsored by Scitech Produtos Medicos Ltda. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by Scitech Produtos Medicos Ltda · Not applicable, Interventional, and Treatment
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To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
Scitech Produtos Medicos Ltda is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Uterine Embolization with PVA Microspheres
Device: Uterine Embolization
Uterine Embolization with PVA Microspheres
Uterine Volume Reduction
Uterine Volume Reduction measured by MRI
Time frame: 6 months
Fibroid Reduction
Fibroid Reduction measured by MRI
Time frame: 6 months
Quality of Life Improvement
Quality of Life Improvement measured by UFS-QOL
Time frame: 6 months
Ovarian Function
Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2018 to primary completion in Feb 2020, 18 months.
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Myofibroma
Scitech Produtos Medicos Ltda