Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
29
14.6.
Summary of the Post-Approval Study Results
14.6.1.
Final safety findings (key endpoints)
There were no significant differences between the acute serious events arising from the procedures performed
by the investigators in the pivotal study compared to those of the investigators in the postmarket surveillance
study.
Table 14.2
provides a summary of serious complications reported (primary endpoint) and incidence of complications
related to the investigator-surgeon (secondary endpoint) in the postmarket surveillance study. There were no acute
serious complications. There was only one (1) serious complication (fever of unknown origin requiring hospitalization)
which was categorized a “near-term” as it occurred more than 48 hours after the procedure.
Table 14.2
Overall Summary of Serious Complications
1
Related to Subject Safety; Timing of Serious Complications, and Incidence
by Investigator-Surgeons Trained (Postmarket Surveillance Study)
Category
Number (%)
Subjects Reporting at Least One Serious Complication (Subsets Below)
1/105 (0.95%)
•
Subjects Reporting at Least One Serious Anesthesia-Related Complication
0/105 (0.0%)
•
Subjects Reporting at Least One Serious Abdominal Entry Related Complication
0/105 (0.0%)
•
Subjects Reporting at Least One Serious Uterine Related
2
Complication
1/105 (0.95%)
Rate of Acute Serious Complications (occurring within 48 hours of Treatment)
0/101 (0.0%)
3
Rate of Near-Term Serious Complications (occurring between 2 and 30 days post treatment)
1/104 (0.96%)
3
Incidence of serious complications per investigator-surgeon during training and post training.
1/29, 3.4%
1
Serious complications are serious adverse events that are treatment related, i.e., related to anesthesia, abdominal entry, or
uterine entry, manipulation, or treatment during the procedure.
2
Uterine related - Related to uterine entry, manipulation, or treatment
3
Percentages are based on the number of subjects who participated in that follow-up visit.
For the acute serious complication rate, the null hypothesis was that the acute serious complication rate for the Acessa procedure is
no different than the observed acute treatment-related SAE rate of 1.46% in the pivotal study. The alternative hypothesis is that the
acute serious complication rate is different. Setting a two-sided alpha level to 0.05 and the sample size to 100, the power to detect a
difference in the acute serious complication rate is at least 0.80 if the true acute serious complication rate is at least 6.7%
For the near-term serious complication rate, the null hypothesis is that the near-term serious complication rate is no different than
the observed near-term treatment-related SAE rate of 0.73% in the pivotal study. The alternative hypothesis is that the near-term
serious complication rate is different.
Table 14.3
provides a comparison of the pivotal study (premarket) and postmarket
surveillance serious complications. In the pivotal study, there were two (2) acute serious complications (2/137, 1.46%) compared to
no acute serious complications in the postmarket surveillance study (0/101, 0.0%). Both studies reported one (1) serious
complication in the near-term follow up phase for a rate of less than 1% in each study. Therefore, both null hypotheses are accepted.
Table 14.3 -
Serious Events Compared: Premarket vs. Postmarket Data (Primary Endpoint)
Serious Events/Complications Related
to Device or Procedure -
ACUTE/48 hours
(Window 24-72 hours)
Pivotal Study (Premarket)
Total N in Safety Group = 137
Postmarket Surveillance
Total N in Safety Group = 105
N
Event
Rate
N Event
Rate
Related to Anesthesia?
1
Atelectasis
0.73%
0 N/A
0%
Related to Abdominal Entry during
procedure?
0
N/A
0%
0 N/A
0%
Related to Uterine
Entry/Manipulation/Treatment
1
Colon laceration
0.73%
0 N/A
0%
Serious Events/Complications Related
to Device or Procedure -
NEAR TERM/30 days
(Window 4-8 weeks)
N
Event
Rate
N Event
Rate
Related to Anesthesia?
0
N/A
0%
0 N/A
0%
Related to Abdominal Entry during
procedure?
0
N/A
0%
0 N/A
0%
Related to Uterine
Entry/Manipulation/Treatment
1
Pelvic Abscess
0.73%
1 Fever of Unknown Origin
0.96%
