Boston Scientific Contour Mode D'emploi page 7

agrees to continue without change in the regimen for the study duration (through
6-month follow-up)
• Subject was willing and able to complete the follow-up requirements outlined in
the study design section of the protocol
• Subject was willing to sign a consent form
Subjects in the UfE arm had to meet all of the following additional criteria to be
eligible to be enrolled into the study:
• Subject did not desire pregnancy
• Creatinine levels were within normal ranges
• If subject is currently on hormonal contraceptives, subject had taken hormonal
contraceptive for ≥ 3 months prior to study enrollment and agreed to continue
without change in the regimen for the study duration (through 6-month follow-up)
Subjects in the myomectomy arm could also meet the following additional criteria and
still be eligible to be enrolled into the study:
• Subjects whose symptom was infertility related to fibroids
• Subjects to be treated GnRH agonists e.g., Lupron Depot™ Pharmaceutical
(leuprolide acetate for depot suspension) may be enrolled if their therapy is
started prior to the procedure but after taking the UFQoL questionnaire and
remaining within the 60-day window
• Fibroids could be removed via laparoscopic myomectomy
Exclusion Criteria
Subjects who met any of the following criteria were not enrolled into the study:
• Fibroid(s) could only be removed by hysteroscopic myomectomy
• Active pelvic infection
• Known or suspected gynecologic malignancy
• Undiagnosed pelvic mass outside of the uterus (not expected to be functional
in nature).
• Unexplained abnormal menstrual bleeding
• Acute or chronic infection (e.g., kidney, bladder, lung, etc.)
• Subject with coagulopathy
• Prior history of pelvic irradiation
• American Society of Anesthesiologists (ASA) score greater than or equal to IV
• Random FSH value ≥ 40 IU/L
• Participating in any other investigational device or drug study
Subjects in the UfE arm who met any of the following additional criteria were not
enrolled into the study:
• Uterine arteriovenous fistula.
• Known severe contrast allergy.
• Pedunculated subserosal fibroid (attachment to uterus is less than 30% of the
greatest diameter of the fibroid).
additional Inclusion Criteria to Continue Participation:
• Subjects were required to complete the baseline UFQoL in order to participate in
the study.
• Subjects were required to have a baseline score on the Overall Fibroid Symptom
component of the UFQoL of ≤ 90 points with the exception of myomectomy
subjects whose fibroids were a cause of infertility and who may not present with
the symptoms of bulk/pressure or abnormal menstrual bleeding.
• Subjects from all cohorts could not be pregnant and this had to be confirmed by a
pregnancy test on the day of, but prior to the procedure.
For subjects that met all of the inclusion and none of the exclusion criteria, subject
demographics (Table 1), medical history, gynecological history, menstrual history,
symptom assessment, imaging evaluation, and pre-procedure labs were collected prior
to treatment.
All subjects had to have a baseline magnetic resonance imaging (MRI) prior to the UFE
or myomectomy procedure. All MRI films were sent to a core laboratory for evaluation
in order to provide consistent and non-biased measurement analysis.
Subjects were evaluated at 3 and 6 months during the study. The subjects in the UFE arm
were then followed annually for up to three years to assess their long-term outcomes.
Table 1. Subject Demographics
age
Mean
Std Dev
race/Ethnicity
Caucasian
African American
Hispanic
Asian
Native American
Other
Height (inches)
Mean
Std Dev
weight (lbs)
Mean
Std Dev
Prior fibroid Treatment
Previous Myomectomy
7
UfE cohort Myomectomy Cohort
(n=149) (n=60)
43.9 38.2
3.58 5.16
71 (47.7%) 22 (36.7%)
65 (43.6%) 29 (48.3%)
8 (5.4%) 4 (6.7%)
3 (2.0%) 3 (5.0%)
0 (0.0%) 1(1.7%)
2 (1.3%) 1 (1.7%)
64.9 64.4
2.78 3.23
159.7 165.9
32.10 41.45
24 (16.1%) 7 (11.7%)