LeiomyomaPhase 1NCT00361036
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent
A Phase 1 study testing Uterine fibroid embolization BeadBlock™ and Uterine fibroid embolization Embosphere® in people with Leiomyoma and Leiomyomatosis, run by Worthington-Kirsch, Robert L., M.D. at 2 sites in United States.
Trial summary
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison of primary safety endpoints to Embosphere. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Leiomyoma, Leiomyomatosis, Uterine Neoplasms
- What is being tested?
- Uterine fibroid embolization BeadBlock™ and Uterine fibroid embolization Embosphere®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Mar 2010
- Phase
- Phase 1
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient chooses to participate and has signed informed consent
- Age between 30 and 50 years old
- Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.
- Patient has fibroids confirmed by MRI
- Patient has normal kidney function.
- Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE.
Who cannot join
- Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.
- Patients with a history of gynecologic malignancy
- Patients with known endometrial hyperplasia
- Patients with adenomyosis
- Patients with pelvic inflammatory disease
- Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks
Show all 13Show fewer
- Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus.
- Patients with pelvic pain as dominant syndrome
- Known allergy to contrast media that cannot be adequately pre-medicated.
- Patients not suitable for arterial access.
- Previous uterine artery embolization attempts.
- History of pelvic irradiation.
- Patients on GnRH Therapy within 3-6 months prior to the study enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albany Medical Center
Albany, New York, 12208
Image Guided Surgery Associates
Pottstown, Pennsylvania, 19464
About this study
Official title: Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison of primary safety endpoints to Embosphere.
Read the detailed description
The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a 12 months study (12 month follow up for all enrollees). The primary end-point will be the degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/- 15 days) after UAE procedure. In addition we will assess symptom reduction in patients that have undergone uterine fibroid embolization with Bead Block™ and Embosphere®.
Primary Objective 1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
Secondary Objective
- To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
Tertiary Objective
- To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
- To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and compare the changes between BeadBlock™ and Embosphere.
- Conditions
- Leiomyoma, Leiomyomatosis, Uterine Neoplasms
- Being tested
- Uterine fibroid embolization BeadBlock™, Uterine fibroid embolization Embosphere®
- Keywords
- Leiomyoma, Leiomyomatosis, Uterine Neoplasms, BeadBlock, Embsophere, Embolization, Uterine fibroid embolization
- Medical subject headings
- Leiomyoma, Leiomyomatosis, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine fibroid embolization BeadBlock™Device
Intervention with BeadBlock Microspehere
Uterine fibroid embolization Embosphere®Device
Embosphere - control arm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BeadBlock treatment arm Receives: Device: Uterine fibroid embolization BeadBlock™ |
| 2 | Active comparator | Embospheres control arm Receives: Device: Uterine fibroid embolization Embosphere® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fibroid devascularization as seen at contrast enhanced MRI performed several days after UAE and 3 months following the UAE between BeadBlock™ and Embosphere
Measured: 12 months
Secondary outcomes (2)
Mean difference of change in fibroid devascularization CEMRI performed several days after UAE and 6 months following the UAE between BeadBlock™ and Embosphere.
Measured: 12 months
assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Worthington-Kirsch, Robert L., M.D.
- Collaborators
- Terumo Medical Corporation, Biocompatibles UK Ltd
- Investigators
- Robert Worthington-Kirsch, MD, Principal investigator, Image Guided Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361036
- Sponsor's protocol ID
- G060030
- Status last verified
- Apr 2011
- First submitted
- 3 Aug 2006
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Worthington-Kirsch RL, Siskin GP, Hegener P, Chesnick R. Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial. Cardiovasc Intervent Radiol. 2011 Jun;34(3):493-501. doi: 10.1007/s00270-010-0049-y. Epub 2010 Dec 3.
PubMed 21127866
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®
- ClinicalTrials.gov ID
- NCT00361036
- Acronym / sponsor ID
- G060030
- Conditions
- Leiomyoma, Leiomyomatosis, Uterine Neoplasms
- Keywords
- Leiomyoma, Leiomyomatosis, Uterine Neoplasms, BeadBlock, Embsophere, Embolization, Uterine fibroid embolization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Worthington-Kirsch, Robert L., M.D.
- Collaborators
- Terumo Medical Corporation, Biocompatibles UK Ltd
- Study start
- Aug 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Aug 2006 (estimated)
- 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.
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison of primary safety endpoints to Embosphere.
Detailed description
The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a 12 months study (12 month follow up for all enrollees). The primary end-point will be the degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/- 15 days) after UAE procedure. In addition we will assess symptom reduction in patients that have undergone uterine fibroid embolization with Bead Block™ and Embosphere®.
Primary Objective 1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
Secondary Objective
- To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
Tertiary Objective
- To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the UAE, and compare the changes between BeadBlock™ and Embosphere.
- To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and compare the changes between BeadBlock™ and Embosphere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Uterine fibroid embolization BeadBlock™BeadBlock treatment arm |
| 2 | Active comparator | Device: Uterine fibroid embolization Embosphere®Embospheres control arm |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient chooses to participate and has signed informed consent
- Age between 30 and 50 years old
- Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.
- Patient has fibroids confirmed by MRI
- Patient has normal kidney function.
Key exclusion criteria (13 listed)
- Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.
- Patients with a history of gynecologic malignancy
- Patients with known endometrial hyperplasia
- Patients with adenomyosis
- Patients with pelvic inflammatory disease
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 fibroid embolization BeadBlock™Intervention with BeadBlock Microspehere | Device | 1 |
| Uterine fibroid embolization Embosphere®Embosphere - control arm | Device | 2 |
Primary outcome
Change in fibroid devascularization as seen at contrast enhanced MRI performed several days after UAE and 3 months following the UAE between BeadBlock™ and Embosphere
Time frame: 12 months
2 secondary outcomes
Mean difference of change in fibroid devascularization CEMRI performed several days after UAE and 6 months following the UAE between BeadBlock™ and Embosphere.
Time frame: 12 months
assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up
Time frame: 12 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 18 Apr 2011.
- Derived from this study: PubMed 21127866Worthington-Kirsch RL, Siskin GP, Hegener P, Chesnick R. Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial. Cardiovasc Intervent Radiol. 2011 Jun;34(3):493-501. doi: 10.1007/s00270-010-0049-y. Epub 2010 Dec 3.
- Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine FibroidsLink provided by the sponsor.
- Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): peri- and postprocedural results from a randomized controlled trialLink provided by the sponsor.
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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.
Robert Worthington-Kirsch, MD principal investigator
Image Guided Surgery Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Uterine fibroid embolization BeadBlock™ and Uterine fibroid embolization Embosphere® in people with Leiomyoma and Leiomyomatosis, run by Worthington-Kirsch, Robert L., M.D. at 2 sites in United States.
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 6 inclusion and 13 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 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in fibroid devascularization as seen at contrast enhanced MRI performed several days after UAE and 3 months following the UAE between BeadBlock™ and Embosphere (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361036, which also lists 1 linked publication.
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 18 Apr 2011.