Uterine FibroidNCT03427671
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
A study testing Occlusin 500 Microspheres in people with Uterine Fibroid and Myoma, run by IMBiotechnologies Ltd. at 1 site in Canada.
Trial summary
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroid, Myoma, Leiomyoma
- What is being tested?
- Occlusin 500 Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2018to 3 Sep 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Premenopausal women with symptomatic uterine fibroids
- Willing and able to provide informed consent
- Fibroids visible by ultrasound or non-contrast magnetic resonance imaging
- Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc
- Documented ovulation by Luteinizing Hormone (LH) testing
- Follicle Stimulating Hormone (FSH) value >40 IU/L within 3 months prior to procedure
- Pelvic examination within 6 months prior to procedure
- Normal Pap smear
Who cannot join
- Positive pregnancy test
- Uterine size > 20 weeks gestation
- Fibroids that are more than 50% submucosal
- Individual fibroids > 12cm in diameter, or total fibroid burden > 905cc
- Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid
- Fibroids situated in the cervix
Show all 28Show fewer
- Abnormally large ovarian arteries
- Uterine pathology other than fibroids
- History of gynecologic malignancy
- Active pelvic infection or history of pelvic inflammatory disease
- Undiagnosed pelvic mass outside the uterus
- History of chemotherapy or radiation to the abdomen or pelvis
- Intra-Uterine Device (IUD) in position
- History of, or ongoing, hemolytic anemia
- Severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment
- Anticoagulant therapy or known bleeding disorder
- Treatment with Gonadotropin Releasing Hormone (GnRH) agonists within the previous 6 weeks
- Received another investigational agent within past 12 weeks
- Compromised hematopoietic function
- Compromised hepatic function
- Compromised renal function
- BMI > 38
- Claustrophobia
- Contraindication to angiography
- Contraindication to magnetic resonance imaging (MRI) or MRI contrast agents
- Allergy to contrast agents
- Allergy to bovine collagen
- Patient desires to become pregnant, or does not agree to contraception during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
Read the detailed description
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.
- Conditions
- Uterine Fibroid, Myoma, Leiomyoma
- Being tested
- Occlusin 500 Microspheres
- Medical subject headings
- Leiomyoma, Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusin 500 MicrospheresDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Occlusin 500 microspheres | Experimental | Uterine fibroid embolization Receives: Device: Occlusin 500 Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Measured: 6 months post-embolization
Secondary outcomes (5)
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Measured: 1 month post-embolization
Uterine volume
Magnetic Resonance Imaging-determined uterine volume
Measured: 6 months post-embolization
Fibroid volume
Magnetic Resonance Imaging-determined fibroid volume
Measured: 1 month post-embolization
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Measured: 1 month post-embolization
Quality of Life Assessment
Uterine Fibroid Symptom Assessment by Questionnaire
Measured: 6 month post-embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start17 Jan 2018
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMBiotechnologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Owen, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427671
- Sponsor's protocol ID
- OCL500-P3-UFE-02
- Status last verified
- Sep 2019
- First submitted
- 4 Feb 2018
- Last updated
- 12 Sep 2019
- 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 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT03427671
- Acronym / sponsor ID
- OCL500-P3-UFE-02
- Conditions
- Uterine Fibroid, Myoma, Leiomyoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IMBiotechnologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 9 Feb 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.
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occlusin 500 microspheres | Experimental | Device: Occlusin 500 MicrospheresUterine fibroid embolization |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Premenopausal women with symptomatic uterine fibroids
- Willing and able to provide informed consent
- Fibroids visible by ultrasound or non-contrast magnetic resonance imaging
- Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc
- Documented ovulation by Luteinizing Hormone (LH) testing
Key exclusion criteria (28 listed)
- Positive pregnancy test
- Uterine size > 20 weeks gestation
- Fibroids that are more than 50% submucosal
- Individual fibroids > 12cm in diameter, or total fibroid burden > 905cc
- Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid
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 |
|---|---|---|
| Occlusin 500 MicrospheresOcclusin 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. | Device | Occlusin 500 microspheres |
Primary outcome
Fibroid volume
Time frame: 6 months post-embolization
Magnetic Resonance Imaging-determined fibroid volume
5 secondary outcomes
Uterine volume
Time frame: 1 month post-embolization
Uterine volume
Time frame: 6 months post-embolization
Fibroid volume
Time frame: 1 month post-embolization
Quality of Life Assessment
Time frame: 1 month post-embolization
Quality of Life Assessment
Time frame: 6 month post-embolization
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 12 Sep 2019.
- 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.
Richard Owen, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusin 500 Microspheres in people with Uterine Fibroid and Myoma, run by IMBiotechnologies Ltd. at 1 site in Canada.
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 8 inclusion and 28 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 12 Sep 2019. 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 Canada. 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?
Fibroid volume (time frame: 6 months post-embolization). 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 12 Sep 2019.