Hologic Acessa ProVu, User Manual

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Acessa ® ProVu System User’s Guide PL-01-0040
CO 20-131 Revision: C 24
Types and Number of Fibroids Treated in the Study
Variable N = 135
2
Number of fibroids treated per patient 1 to 29
Mean number of fibroids treated per patient 5
Median number of fibroids treated per patient 4
Number of total fibroids treated within the study 674
Types of fibroids
1
Intramural 347
Subserosal 193
Submucosal 164
Transmural 39
Missing Type 18
Location of fibroids
1
Fundal 148
Mid Uterus 41
Lower Uterine 118
Anterior 235
Posterior 236
Left 144
Right 153
Broad Ligament 2
Missing Location 2
1
A fibroid may be in more than one location or be of more than one type.
2
Full analysis set excludes two subjects who did not meet the bleeding criteria
13.6. Results of the Pivotal Study
Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered “evaluable” in terms of their
1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle,
3) baseline menstrual blood loss was within protocol inclusion limits. The table below shows the subject disposition at
12 months post treatment.
Subject Disposition at 12 Months Post Treatment
n (%)
Total Treated 137 (100%)
Evaluable for Menstrual Blood Loss Using Alkaline Hematin * 124 (90.5%)
Withdrew prior to 12 months * 2
Lost to follow up * 1
Pregnant 3
Menstrual blood loss baseline outside protocol inclusion limits 2
Hashimoto’s Disease 1
Menopause/amenorrhea 4
*The primary full analysis set (PFAS, N=127) for bleeding relief is composed of subjects who withdrew, were lost to
follow up, or are evaluable.
Subject Disposition at 24 and 36 Months Post Treatment
n (%)
Total Evaluable at 12 months 124 (100%)
Withdrew or lost to follow up between 12 and 24 months 3
Withdrew or lost to follow up between 24 and 36 months 2
Pregnant 1
12-24 month reintervention 6
24-36 month reintervention 4
Elective endometrial ablation 1
*3 additional subjects underwent a reintervention after the 36 month visit was completed.
13.7. Safety
Summary of Treatment-Emergent Adverse Events by Relationship to the Device, Laparoscopic Procedure, and/or
Classified as Serious.
Urinary tract infection, which was reported in 7 of the 137 subjects (5.1%) was the most commonly reported adverse
event during the three year follow up followed by bacterial vaginitis (6/137, 4.4%), influenza (4/137, 2.9%), pharyngitis
(4/137, 2.9%), lower abdominal pain (4/137, 2.9%) and dizziness (4/137, 2.9%).