Results Of The Pivotal Study; Safety - Hologic Acessa ProVu User Manual

Acessa ProVu System User's Guide
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Types and Number of Fibroids Treated in the Study
Number of fibroids treated per patient
Mean number of fibroids treated per patient
Median number of fibroids treated per patient
Number of total fibroids treated within the study
Types of fibroids
Location of fibroids
A fibroid may be in more than one location or be of more than one type.
1
Full analysis set excludes two subjects who did not meet the bleeding criteria
2
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
Total Treated
Evaluable for Menstrual Blood Loss Using Alkaline Hematin*
Withdrew prior to 12 months*
Lost to follow up*
Pregnant
Menstrual blood loss baseline outside protocol inclusion limits
Hashimoto's Disease
Menopause/amenorrhea
*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
Total Evaluable at 12 months
Withdrew or lost to follow up between 12 and 24 months
Withdrew or lost to follow up between 24 and 36 months
Pregnant
12-24 month reintervention
24-36 month reintervention
Elective endometrial ablation
*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%).
CO 20-131 Revision: C
Variable
Intramural
Subserosal
1
Submucosal
Transmural
Missing Type
Fundal
Mid Uterus
Lower Uterine
Anterior
1
Posterior
Left
Right
Broad Ligament
Missing Location
N = 135
2
1 to 29
5
4
674
347
193
164
39
18
148
41
118
235
236
144
153
2
2
n (%)
137 (100%)
124 (90.5%)
2
1
3
2
1
4
n (%)
124 (100%)
3
2
1
6
4
1
PL-01-0040
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