Hologic NovaSure Advanced, Инструкция по использованию и руководство оператора контроллера

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Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients
NovaSure
(n=175)
Wire Loop Resection
Plus Rollerball
(n=90)
Months post ablation 12* 24** 36** 12* 24** 36**
Number of
successful patients 136 143 134 67 68 63
Study success rate 77 .7% 81 .7% 76 .6% 74 .4% 75 .6% 70 .0%
# of patients with
Amenorrhea 63 64 58 29 26 23
Amenorrhea rate 36 .0% 36 .6% 33 .1% 32 .2% 28 .9% 25 .6%
* Based on diary scores
** Based on telephone questionnaires
Secondary effectiveness endpoint: quality of life
Patient quality of life (QOL) was assessed by administering the quality of
life questionnaire (SF-12) and the menstrual impact questionnaire prior
to treatment and at 3, 6, 12, 24 and 36 months post-procedure . Table 4
shows the patient responses for both groups pre-operatively, where
appropriate, and at 12, 24 and 36 months post-procedure .
Table 4. Effectiveness: Quality of Life (QOL)
NovaSure
Wire Loop Resection
Plus Rollerball
Number of Patients Responding to Quality of Life Questionaire
#
Pre-operatively 175 90
12 Months 154 82
24 Months 143 73
36 Months 139 67
Percent of Patients Satisified Or Very Satisified
12 Months 92 .8% 93 .9%
24 Months 93 .9% 89 .1%
36 Months 96 .3% 89 .7%
Percent of Patients Who Probably Or Definitely Would Recommend
This Procedure
12 Months 96 .7% 95 .9%
24 Months 96 .6% 94 .5%
36 Months 97 .8% 92 .6%
Percent of Patients with Dysemenorrhea
Pre-operatively 57 .1% 55 .6%
12 Months 20 .8%
& 34 .2% *,&
24 Months 20 .3%* 30 .1%*
36 Months 17 .3%* 28 .4%*
Percent of Patients with PMS
Pre-operatively 65 .1% 66 .7%
12 Months 36 .4%* 35 .4%*
24 Months 44 .0%* 46 .6%*
36 Months 34 .5%* 41 .2%*
Percent of Patients Reporting Sometimes, Frequently Or Always
Have Difficulty Performing Work Or Other Activities Due to Menses
Pre-operatively 66 .3% 65 .5%
Table 4. Effectiveness: Quality of Life (QOL)
NovaSure
Wire Loop Resection
Plus Rollerball
12 Months 9 .9%* 8 .6%*
24 Months 14 .5%* 15 .0%*
36 Months 16 .3%* 13 .3%*
Percent of Patients Reporting Sometimes, Frequently Or Always
Feel Anxious Due to Menses
Pre-operatively 74 .7% 68 .9%
12 Months 23 .6%* 18 .5%*
24 Months 24 .2%* 19 .2%*
36 Months 18 .7%* 19 .1%*
Percent of Patients Reporting Sometimes, Frequently Or Always
Miss Social Activities Due to Menses
Pre-operatively 63 .3% 62 .2%
12 Months 8 .5%* 8 .6%*
24 Months 9 .0%* 11 .1%*
36 Months 8 .1%* 10 .8%*
# Not all patients completed questionnaire
* Statistically significant difference from pre-operative response (Chi-Square; p < 0 .05)
& Statistically significant difference between NovaSure and Rollerball Groups
(Chi-Square; p = 0 .02)
Safety endpoint
Adverse event information is described in the “Adverse Events” section
of this manual .
Secondary endpoint: procedure time
Procedure time, a secondary endpoint, was determined for each patient
by recording the time of device insertion and the time of device removal .
The mean procedure time for the NovaSure patients was significantly
less than the procedure time for the rollerball group, (4 .2 ± 3 .5 minutes
and 24 .2 ± 11 .4 minutes, respectively) . Mean time for application of RF
energy was 84 .0 ± 25 .0 seconds in a subset of monitored NovaSure
patients (Table 5) .
Table 5. Operative Procedure Time
Operative Parameters
NovaSure
n=175
Wire Loop Resection
Plus Rollerball
n=90
Number of treated patients* 171 88
Procedure time minutes (± SD)
(Device insertion to device
removal)
4 .2 ± 3 .5** 24 .2 ± 11 .4**
Procedure time in seconds (±SD)
(Time of energy delivery) 84 .0 ± 25 .0 ND
#
* See Table 2 for patient accountability
** Statistically significant difference between treatment groups (Student’s t-test; p < 0 .05)
#
Not determined