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Acessa
ProVu System User's Guide
®
14.6.2. Study Strengths and Weaknesses
The target number of subjects was 100; however, the Sponsor allowed for a 5% over-recruitment to account
for withdrawals, missed visits, and loss to follow up before 30 days. Each enrolling site contributed at least one
(1) subject but no site contributed in excess of 22 subjects (21% of the total). Over 60% of the subject data
come from the United States (U.S.). A weakness of this study is the small number of ethnic minority subjects,
particularly Hispanic/Latin American women. Table 14.4 provides the demographic data regarding the 105
treated subjects. The results of the postmarket surveillance study were consistent with results of the pivotal
study, demonstrating the studies are reliable benchmarks for safety.
Table 14.4: Demographics of subject population
Variable
Age (Yrs)
Height (cm)
Weight (kg)
Ethnicity
15. Potential Ris ks of Acessa ProVu System
Known risks associated with radiofrequency ablation of fibroids include: skin burn, mild intra-operative bleeding, transient urinary
retention or urinary tract infection, adhesion formation, post-procedural discomfort (cramping, pelvic pain), and transient
amenorrhea:
•
The risk of skin burn from the dispersion of radiofrequency energy is minimal and is a common risk for electrosurgical
procedures.
Bleeding may be observed due to injury to blood vessels in the area that the sharp electrosurgical device is inserted
•
and deployed. Hemorrhage may occur from thermal injury to large blood vessels in the area ablated.
Urinary retention or urinary tract infection are common complications following bladder catheterization.
•
•
The formation of adhesions (scar tissue formation) following laparoscopic surgery is an inherent risk to the procedure.
•
Cramping or pelvic pain may be experienced after the procedure and may require non-steroidal anti-inflammatory
drugs (NSAID) or other analgesic medication for relief.
•
There is a possibility that transient amenorrhea may result from this or any surgical procedure due to the effects of
surgery and anesthesia on hypothalamic function.
Additional potential risks include: infection, injury to adjacent structures, vaginal bleeding and temporary anemia, blood loss
requiring transfusion or hysterectomy, pneumothorax, wound dehiscence, deep vein thrombosis and pulmonary embolus,
treatment failure, and complications related to laparoscopy and/or general anesthesia, including death.
After radiofrequency ablation of fibroids, instrumentation of the uterine cavity should be performed with caution and only when
absolutely necessary.
CO 20-131 Revision: C
Mean (SD)
Median
Min
Max
Mean (SD)
Median
Min
Max
Mean (SD)
Median
Min
Max
Caucasian
Chinese
Korean
Black
Latin American
Japanese
Filipino
Aboriginal
South Asian
SE Asian
West Asian
PL-01-0040
(N=105)
470.5 (6.88)
40.0
21
54
164.18 (8.007)
164.20
147.3
185.0
77.81 (19.432)
73.00
48.6
137.0
43 (41.0%)
2 (1.9%)
1 (1.0%)
39 (37.1%)
4 (3.8%)
0 (0.0%)
3 (2.9%)
2 (1.9%)
2 (1.9%)
0 (0.0%)
0 (0.0%)
30
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