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Exclusion criteria
• Presence of bacteremia, sepsis or other active systemic infection
• Active or recurrent chronic pelvic inflammatory disease
• Patient with documented coagulopathies or on anticoagulants
• Symptomatic endometriosis
• Prior uterine surgery (except low segment cesarean section)
that interrupts the integrity of the uterine wall e .g ., transmural
myomectomy or classical cesarean section
• Prior endometrial ablation
• Patient on medications that could thin the myometrial muscle, such as
long-term steroid use
• Patient desire to have children or to preserve fertility
• Patient currently on hormonal birth control therapy or unwilling to use
a non-hormonal birth control post-ablation
• Abnormal/obstructed cavity as confirmed by hysteroscopy, SIS or HSG .
Specifically:
- septate or bicornuate uterus or other congenital malformation of the
uterine cavity
- pedunculated, submucous leiomyomata or other leiomyomata which
distort the cavity; polyps (larger than 2 cm) which are likely to be the
cause of the patient’s menorrhagia
- presence of an IUD
• Suspected or confirmed uterine malignancy within the last five years
as confirmed by histology
• Endometrial hyperplasia as confirmed by histology
• Unaddressed cervical dysplasia
• Elevated FSH levels consistent with ovarian failure >40 IU/ml
• Pregnancy
• Active sexually transmitted disease
Patient population:
A total of 265 patients were enrolled in this study .
Patients were between the ages of 25 to 50 with 46% under the age
of 40 and 54% 40 years of age or older . There were no differences in
demographic or gynecological history parameters between the treatment
groups, between the age groupings or among the nine investigational
sites .
Table 2. Patient Accountability
Number of Patients
NovaSure
Wire Loop
Resection
Plus Rollerball
Entered into Study
(Intent-to-Treat population)
175
90
Aborted procedures*
1
-4
-2
Treated
171
88
Additional treatment*
-4
-2
Hysterectomy*
2
-3
-2
Table 2. Patient Accountability
Number of Patients
NovaSure
Wire Loop
Resection
Plus Rollerball
Lost to follow-up*
-5
-2
Hodgkin’s disease*
-1
0
Pelvic Pain - administered
leuprolide*
-1
0
12-Month
follow-up data available
157
82
Additional treatment*
-2
-1
Hysterectomy*
2
-3
-1
Lost to follow-up*
-2
-5
Missed visit
-1
-1
Declined to participate*
-1
0
Pregnancy*
-1
0
24-Month
follow-up data available
147
74
Additional treatment*
0
-4
Hysterectomy*
2
-5
-1
Lost to follow-up*
-4
-2
36-Month follow-up
138
67
Subject lost to follow-up at
24 mos ., returned at 36 mos .
+1
+1
36-Month follow-up data
available
139
68
* Discontinued patients
1
Four NovaSure did not meet protocol Inclusion Criteria; Two Rollerball had uterine perforation
2
For hysterectomy, see Table 7
Results
Primary effectiveness endpoint: bleeding score
Patient success at 12-months post-procedure is defined as a reduction
in diary score from >150 pre-operatively to <75 post-procedure .
Amenorrhea is defined as a score of 0 . Success at 24 and 36 months,
based on telephone questionnaires, is defined as elimination of bleeding
or reduction to light or normal flow . Data presented in Table 3 (below)
represent the clinical results based on the total number of 265 patients
randomized (Intent-to-Treat group (ITT)) for the study . The worst-case
scenario is presented whereby each of the discontinued patients
(described in Table 2 for patient accountability) is counted as a “failure”
for calculating the values listed in the table .
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