Uterine FibroidNCT03072446
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
A study testing Gel-Beads embolic material in people with Uterine Fibroid and Embolization, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid, Embolization, Symptoms
- What is being tested?
- Gel-Beads embolic material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2017to 30 Sep 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age 18 years or older
- Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment
- Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study
- Willing to provide written informed consent prior to initiation of study procedures
- Willing to comply with the specified study assessments and follow-up requirements
Who cannot join
- Known hypersensitivity to porcine products or intravascular contrast material
- Vascular anatomy or blood flow precluding correct catheter placement or embolic injection
- Presence of collateral vessel pathways potentially endangering normal territories during embolization
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton University Hospital NHS Trust
Southampton, Hampshire, SO16 6YD
About this study
The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.
Read the detailed description
This single-center, prospective study will be conducted at one site in the United Kingdom. Up to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead subjects will be followed at 1-month and 3-months post-procedure.
Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton. This study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.
- Conditions
- Uterine Fibroid, Embolization, Symptoms
- Being tested
- Gel-Beads embolic material
- Keywords
- Uterine Fibroid, Embolization, symptoms, Gel-Beads
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel-Beads embolic materialDevice
Patients will receive embolization of their uterine fibroids using Gel-Beads.
| Study group | Role | What they receive |
|---|---|---|
| Gel-Beads arm | Experimental | This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent Receives: Device: Gel-Beads embolic material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Fibroid Tissue Infarction at 3 months
The primary endpoint is the degree of fibroid tissue infarction at 3 months post-procedure. Results for the total fibroid load and the dominant fibroid will be categorized as either 100% (Group A) ≥ 90-99% (Group B) or <90% (Group C) infarcted. The degree of infarction will be visually estimated by the investigator.
Measured: 3 months
Characterization of adverse events over 3 months
The primary safety endpoint is to characterize adverse events
Measured: 3 months
Secondary outcomes (1)
Change in uterine and dominant fibroid volumes
Changes in uterine and dominant fibroid volumes between pre-procedure and Month 3 based on CE-MRI. The absolute dimensions of the uterus will be measured and the approximate uterine volumes will be calculated using the formula for a prolate ellipse (length X width X depth X 0.5233).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start24 Apr 2017
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular Solutions LLC
- Responsible party
- Sponsor
- Investigators
- Nigel Hacking, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072446
- Sponsor's protocol ID
- RHM RAD0041
- Status last verified
- May 2019
- First submitted
- 2 Mar 2017
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
- ClinicalTrials.gov ID
- NCT03072446
- Acronym / sponsor ID
- RHM RAD0041
- Conditions
- Uterine Fibroid, Embolization, Symptoms
- Keywords
- Uterine Fibroid, Embolization, symptoms, Gel-Beads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Vascular Solutions LLC
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 7 Mar 2017 (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.
The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.
Detailed description
This single-center, prospective study will be conducted at one site in the United Kingdom. Up to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead subjects will be followed at 1-month and 3-months post-procedure.
Data from subjects treated with Gel-Bead will be compared to data from a previously unpublished, but widely presented, 100-patient cohort study at the University Hospital Southampton. This study evaluated 20 subjects in five different treatment groups for the treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gel-Beads arm | Experimental | Device: Gel-Beads embolic materialThis group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, age 18 years or older
- Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment
- Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study
- Willing to provide written informed consent prior to initiation of study procedures
- Willing to comply with the specified study assessments and follow-up requirements
Key exclusion criteria (3 listed)
- Known hypersensitivity to porcine products or intravascular contrast material
- Vascular anatomy or blood flow precluding correct catheter placement or embolic injection
- Presence of collateral vessel pathways potentially endangering normal territories during embolization
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 |
|---|---|---|
| Gel-Beads embolic materialPatients will receive embolization of their uterine fibroids using Gel-Beads. | Device | Gel-Beads arm |
Primary outcome
Degree of Fibroid Tissue Infarction at 3 months
Time frame: 3 months
The primary endpoint is the degree of fibroid tissue infarction at 3 months post-procedure. Results for the total fibroid load and the dominant fibroid will be categorized as either 100% (Group A) ≥ 90-99% (Group B) or <90% (Group C) infarcted. The degree of infarction will be visually estimated by the investigator.
Characterization of adverse events over 3 months
Time frame: 3 months
The primary safety endpoint is to characterize adverse events
1 secondary outcome
Change in uterine and dominant fibroid volumes
Time frame: 3 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 9 May 2019.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers.
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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.
Nigel Hacking principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel-Beads embolic material in people with Uterine Fibroid and Embolization, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 3 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 9 May 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 United Kingdom. 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?
Degree of Fibroid Tissue Infarction at 3 months (time frame: 3 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 9 May 2019.