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Acessa
ProVu System User's Guide
®
Study Design
13.1.
This prospective, multicenter, longitudinal, single-arm, paired-comparison, interventional study was designed to
evaluate the efficacy and safety of radiofrequency ablation (RFA) treatment of symptomatic uterine fibroids with the
Acessa System. All study subjects who underwent uterine fibroid ablation with the Acessa System were expected to
continue to participate in the study for 36 months following the procedure. Primary endpoint analysis was conducted
at one year post treatment.
13.2.
Study Objectives
13.2.1.
Primary Objectives
The primary objectives of the study were to confirm the safety and efficacy of the Acessa System for the
treatment of symptomatic uterine fibroids.
13.2.2.
Secondary Objectives
The secondary objectives of the study were to evaluate the change in uterine and fibroid volume, symptom
severity, health related quality of life, general health status, and subject satisfaction at 12 months post
treatment compared to baseline.
13.2.3.
Inclusion and Exclusion Criteria
Subjects were included if they were 25 years of age or older, desired uterine preservation but did not desire
current or future childbearing, had symptomatic uterine fibroids, had a uterine gestational size ≤ 14 weeks,
≤ 6 treatable fibroids, with no single fibroid exceeding 7 cm in any diameter as measured by transvaginal
ultrasound and a total uterine fibroid volume that did not exceed 300 cc on ultrasound or contrast-enhanced
MRI evaluation. In addition, the subject was required to have clinical menorrhagia, as indicated by menstrual
blood loss of ≥ 160 mL to ≤ 500 mL along with a 3-month history of menorrhagia within the last 6 months.
Subjects were required to have a normal coagulation profile, a normal Pap smear, and pass a preoperative
health examination (American Society of Anesthesiologists [ASA] physical status I-III). Subjects were excluded
from the study is they had contraindications for laparoscopic surgery and/or general anesthesia, had
undergone pelvic radiation or had a gynecologic malignancy or premalignancy within the past 5 year, had a
non-uterine pelvic mass, had prior pelvic surgery that was known to cause significant intra-abdominal
adhesions or had a history of, or active, pelvic inflammatory disease, had undergone endometrial ablation,
uterine artery embolization, uterine artery ligation, or any other uterine-preserving technique for reduction
of menstrual bleeding, had taken any gonadotropin-releasing hormone (GnRH) agonist within 3 months prior
to the screening, had an implanted intrauterine or fallopian tube device for contraception that could not be
or would not have been removed 1 month prior to treatment, or if they required elective concomitant
procedures. Peri-menopausal and menopausal women were excluded in the study due to the requirement
for collection of used catamenial products. Pregnant or breastfeeding women, women with dysfunctional
uterine bleeding or chronic pelvic pain, adenomyosis, or endometriosis were excluded. Women with cervical
myomas, pedunculated subserosal fibroids or "type zero" (completely intracavitary) submucous fibroids were
also excluded.
13.3.
Study Demographics
A total of 137 women were enrolled and treated in the Acessa Health pivotal study. The study demographics are shown
in the table below.
Demographics
Variable
Age (years)
Race
Ethnicity
CO 20-131 Revision: C
Statistic/Response
n
Mean (SD)
Median
Min, Max
White or Caucasian
Black or African American
Asian
Other
Hispanic or Latino
Not Hispanic or Latino
All Sites (N=137)
137
42.4 (4.72)
43.0
31, 55
62 (45.3%)
46 (33.6%)
2 (1.5%)
27 (19.7%)
62 (45.3%)
75 (54.7%)
PL-01-0040
22
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