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Acessa
ProVu System User's Guide
®
Fibroid Symptoms and Characteristics Reported at Baseline – All Subjects
13.4.
As required by the protocol, all 137 of the subjects reported menorrhagia at baseline and that they had experienced 3
or more heavy periods in the last 6 months. Other than menorrhagia, dysmenorrhea (51.1%), backache (44.5%),
increased abdominal girth (43.8%), and pelvic pressure (43.8%) were the most commonly reported fibroid-related
symptoms at baseline.
Reported Fibroid Symptoms at Baseline
Variable
Fibroid Symptoms
Treatment
13.5.
All 137 enrolled subjects were treated using the following principles of volumetric thermal ablation:
1)
The Handpiece tip was placed approximately 1 cm into the fibroid,
2)
Deployment of the needles was not necessary unless the diameter of the fibroid was ≥ 2 cm,
3)
In cases where deployment of the electrode array was performed, the array was deployed so that the
electrode tips were at least 1 cm away from the fibroid margin in all three planes.
Laparoscopic ultrasound guided the placement of the Handpiece, deployment of the electrode array, and
confirmation of the 1 cm margins before each ablation. The following chart was used to guide the ablation:
Deployment
Setting
Watt
Target Time
sec
1
For 1 cm fibroids
For 1.5 cm fibroids
2
For larger fibroids or fibroids that were more irregular or oval, overlapping ablations were used. In such cases, the
smallest diameter of the fibroid determined the degree of Handpiece insertion and the length of deployment of the
electrode electrode array. Often, the same serosal puncture was used to treat overlapping ablations in one fibroid or
to treat other fibroids in close proximity.
Once an ablation was initiated, the serosa overlying the fibroid was directly observed with the laparoscope. Once all
fibroids were treated appropriately, the array was retracted and the track was coagulated using "coag mode."
CO 20-131 Revision: C
Response
Menorrhagia
Dysmenorrhea
Backache
Increased Abdominal Girth
Pelvic Pressure
Urinary Frequency/Retention
Sleep Disturbance
Dyspareunia
Uterine Pain
Localized Pain
Other
0
0
0.5
15
15
100°C
100°C
Watt
15
1 min
1 min
30 sec
2
1
Appropriate tip placement for spherical, irregular, or oval fibroids
1
1.5
2
100°C
100°C
100°C
2 min
3 min
4 min
PL-01-0040
(N=137)
137 (100.0%)
70 (51.1%)
61 (44.5%)
60 (43.8%)
60 (43.8%)
52 (38.0%)
48 (35.0%)
45 (32.8%)
41 (29.9%)
23 (16.8%)
13 (9.5%)
2.5
3.5
4.5
100°C
100°C
7 min
8 min
12 min
5
100°C
23
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