The purpose of this clinical trial is to compare the safety and efficacy of Embozene® Microspheres for uterine fibroid embolization to Embosphere® for symptomatic relief from uterine fibroids.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
The primary safety endpoint is the frequency of treatment emergent adverse
events. There will be no hypothesis test for this endpoint because the rates of
treatment emergent adverse events for embolization are very small, ranging from
0.04 - 0.2% in the literature.
Secondary outcome
There are three secondary effectiveness endpoints for this study: 1) The
proportion of subjects with at least 90% infarct of the uterine fibroid at 6
months following treatment; 2) The impact of excessive bleeding of fibroids on
quality of life will be assessed with the UFS QOL Questionnaire; And 3) The
need for re-intervention with repeat embolization or other therapy for
treatment failure assessed.
The results over time of the Uterine Fibroid Symptom & Health Related Quality
of Life questionnaire will be compared descriptively. The mean response to
pivotal summary evaluations will be presented for each treatment group, and
within treatment groups the results will be compared to baseline.
Background summary
Uterine fibroid embolization has become accepted as a leading minimally
invasive treatment option for patients with
symptomatic uterine fibroids as reflected by the recent practice guideline by
Spies et al. issued by the American
College of Obstetricians and Gynecologists1.
Embozene Microspheres have a narrow size distribution which provides good
predictability with respect to arterial
transportation. Existing clinical data from Europe provide evidence that the
use of Embozene Microspheres will improve the quality of life of patients to
reduce symptoms associated with symptomatic fibroids, such as abnormal
bleeding, pain, discomfort, and urinary problems.
Biosphere Medical*s Embospheres (K021397), the predicate device cleared for
uterine fibroid embolization in 2002, is currently widely used for UFE
procedures in the US. All studies of Embozene Microspheres, including in vitro
and in vivo studies as well as clinical experiences in Europe provide evidence
of noninferiority to Embospheres®.
Based on the proven performance in comparative bench studies, results of the
FMEA, results reported in the published literature, and similarities and
differences between Embozene Microspheres and similar devices, it is concluded
that the benefits outweigh the risks of the Embozene Microspheres for uterine
fibroid embolization. Furthermore, CeloNova Biosciences has conducted extensive
design verification and validation testing to mitigate the risks associated
with this device. Results from clinical studies conducted in Europe support the
benefits and risks associated with the device and provide evidence that the use
of Embozene Microspheres will improve the quality of life of patients to reduce
symptoms associated with symptomatic fibroids, such as abnormal bleeding, pain,
discomfort, and urinary problems.
Embospheres®, the predicate device that was introduced into practice in the US
in 2002,is widely used for UFE procedure in the US. All studies of Embozene
Microspheres, including in vitro and in vivo studies as well as clinical
experiences in Europe provide evidence of noninferiority to Embospheres®.
Therefore, it is important to conduct this randomized study to demonstrate
substantial equivalence in terms of the safety and efficacy of Embozene
Microspheres.
Study objective
The purpose of this clinical trial is to compare the safety and efficacy of
Embozene® Microspheres for uterine fibroid embolization to Embosphere® for
symptomatic relief from uterine fibroids.
Study design
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.
Intervention
All study participants will have the embolization procedure and the assignment
of the patients to this particular therapeutic strategy falls within current
practice of medicine.
The two treatment groups will have a 2:1 randomization scheme. Each site will
enroll up to a maximum of 35 participants. At least 50% of the subjects will be
from the United States.
The study regimen for each subject will consist of a screening/baseline phase
(Visit 1), the procedure phase (Visit 2), and followup
phase (Visits 39).
The final verification of the patient medical condition can only be done during
surgery. If, during If, during surgery, the physician decides that the patient
is not a suitable candidate for UFE, she will not be included in the study and
will receive a different treatment or no treatment for her condition, as
discussed and agreed upon by both patient and physician prior to surgery.
Study burden and risks
The patient may have side effects while on the study. Everyone taking part in
the study will be watched carefully for any side effects. Adequate information
about all side effects will be provided to the patients by their radiologist
and by the means of the patient information sheet. However, doctors do not know
all the side effects that may occur and it is possible that additional side
effects could occur other than those listed in the information sheet. Patients
must tell the Principal Investigator about any side effects that they have
while taking part in the study so they may properly monitor your health. If
they experience a side effect or injury that may be related to this study or if
they have an unscheduled visit
for medical care for any reason, they could contact the site by phone during a
workday or at night or on weekends.
There is no guarantee that the patients will benefit from study participation.
The study treatment may result in an improvement of their symptoms, such as
reduced bleeding.
18615 Tuscany Stone, 18615
San Antonio TX 78258
US
18615 Tuscany Stone, 18615
San Antonio TX 78258
US
Listed location countries
Age
Inclusion criteria
-Pre-menopausal women age 30-50 years at time of enrollment.
-Heavy menstrual bleeding with or without pain and bulk related symptoms
Exclusion criteria
Pregnant patient or intends to become.
Has HIV or other immunodeficient state
Already infarcted or calcified fibroids present.
Présence or suspicion of malignancy or infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41919.008.12 |