Uterine Fibroids
Conditions
Brief summary
This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.
Interventions
DEVICEEmbozene® Microspheres
DEVICEEmbosphere®
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form. * Pre-menopausal women age 30-50 years at time of enrollment * Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.
Exclusion criteria
* Patient has a history of pelvic malignancy * Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure * Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts). * Is at substantial risk for the need of organ transplantation, such as renal insufficiency. * Patient has evidence of current or recent pelvic inflammatory disease or uterine infection. * Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents. * Patients unable to comply with the follow-up requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 12 Months post study procedure | The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months. |
Countries
United States
Participant flow
Pre-assignment details
11 patients screened and 4 randomized.
Participants by arm
| Arm | Count |
|---|---|
| Embozene® Microspheres Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embozene® Microspheres | 3 |
| Embosphere® Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.
Embosphere® | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Trial terminated by Sponsor | 3 | 1 |
Baseline characteristics
| Characteristic | Embozene® Microspheres | Total | Embosphere® |
|---|---|---|---|
| Age, Continuous | 45 years | 45 years | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 4 participants | 1 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Primary Endpoint
The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.
Time frame: 12 Months post study procedure
Population: The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.