An interventional study of Occlusin 500 Microspheres in Uterine Fibroid, Myoma and Leiomyoma, sponsored by IMBiotechnologies Ltd.. Completed at 1 site in Canada. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by IMBiotechnologies Ltd. · Not applicable, Interventional, and Treatment
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. Following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with Occlusin 500 microspheres.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's enrollment of 12 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →IMBiotechnologies Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Uterine fibroid embolization
Device: Occlusin 500 Microspheres
Occlusin 500 microspheres will be administered using a catheter directed to the uterine vasculature using fluoroscopy. The microsphere suspension will be administered to a near-stasis endpoint.
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Time frame: 6 months post-embolization
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Time frame: 1 month post-embolization
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Time frame: 6 months post-embolization
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Time frame: 1 month post-embolization
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Time frame: 1 month post-embolization
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Time frame: 6 month post-embolization
Ultrasound of Uterus
Qualitative assessment of uterus comparing baseline to post-embolization time points
Time frame: 1 day post-embolization
Ultrasound of Uterus
Qualitative assessment of uterus comparing baseline to post-embolization time points
Time frame: 1 month post-embolization
Ultrasound of Uterus
Qualitative assessment of uterus comparing baseline to post-embolization time points
Time frame: 6 months post-embolization
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Sep 2019, 19 months.
Of 57 interventional studies with no phase under Leiomyoma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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IMBiotechnologies Ltd.