Trial Outcomes & Findings for Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy (NCT NCT03634306)

NCT ID: NCT03634306

Last Updated: 2020-03-10

Results Overview

Measure the quality of visualization in the laparoscopic field of view using a 5 point Visual Analog Scale. 0 is visible interference is imperceptible, 2-3 is perceptible to interfering, 4 is interfering, 5 is highly interfering)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: End of procedure
• Results posted on: 2020-03-10

Participant Flow

Participant milestones

Measure	ARM 1 Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Overall Study STARTED	15	15	5
Overall Study COMPLETED	15	15	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy

Baseline characteristics by cohort

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	Total n=35 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	46.1 years STANDARD_DEVIATION 8.5 • n=7 Participants	37.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	44.5 years STANDARD_DEVIATION 9.5 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	5 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasian	11 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized Black/African-American	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	5 participants n=5 Participants	35 participants n=4 Participants
BMI	30.4 kg/m2 STANDARD_DEVIATION 7.2 • n=5 Participants	33.3 kg/m2 STANDARD_DEVIATION 10.5 • n=7 Participants	32.7 kg/m2 STANDARD_DEVIATION 9.7 • n=5 Participants	32.0 kg/m2 STANDARD_DEVIATION 8.8 • n=4 Participants

PRIMARY outcome

Timeframe: End of procedure

Measure the quality of visualization in the laparoscopic field of view using a 5 point Visual Analog Scale. 0 is visible interference is imperceptible, 2-3 is perceptible to interfering, 4 is interfering, 5 is highly interfering)

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Quality of Surgical Field Visualization Imperceptible Visual Impairment	9 participants	1 participants	5 participants
Quality of Surgical Field Visualization Perceptible Visual Impairment	2 participants	2 participants	0 participants
Quality of Surgical Field Visualization Slightly Interfering	3 participants	7 participants	0 participants
Quality of Surgical Field Visualization Interfering	1 participants	4 participants	0 participants
Quality of Surgical Field Visualization Highly Interfering	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: End of procedure

Amount of CO2 Consumed in liters from placement of all surgical ports to colpotomy (hysterectomy) or closure of last uterine defect (myomectomy)

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Consumed CO2	16.7 Liters Standard Deviation 21.3	23.5 Liters Standard Deviation 23.7	25.7 Liters Standard Deviation 25.3

SECONDARY outcome

Timeframe: Intraoperative

Count of the number of times the operative procedure is interrupted or delayed due to clearing smoke

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Operative Procedure Disruption	1.6 Count of pauses for smoke clearing Standard Deviation 1.7	3.6 Count of pauses for smoke clearing Standard Deviation 2.2	0 Count of pauses for smoke clearing Standard Deviation 0

SECONDARY outcome

Timeframe: End of procedure

Maximum intra-abdominal pressure used measured in mmHg

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Intra-abdominal Pressure	10.7 mmHg Standard Deviation 1.8	12.3 mmHg Standard Deviation 2.6	10 mmHg Standard Deviation 0

SECONDARY outcome

Timeframe: Intraoperative

The number of participants who had an adjustment in intra-abdominal pressure during the procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Number of Participants With Adjusted Intra-abdominal Pressure	2 Participants	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Intraoperative

Duration spent at first intra-abdominal pressure increase from the initial 10mmHg set point

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Duration of Intra-abdominal Pressure Increase	31.5 minutes Standard Deviation 6.4	59.8 minutes Standard Deviation 37.4	0 minutes Standard Deviation 0

SECONDARY outcome

Timeframe: Intraoperative

Temperature in degrees Celsius at time 0 min during operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Temperature at Time 0 Min	35.93 Degrees Celsius Standard Deviation 0.49	35.75 Degrees Celsius Standard Deviation 0.51	35.96 Degrees Celsius Standard Deviation 0.48

SECONDARY outcome

Timeframe: Intraoperative

Temperature in degrees Celsius at 15 min during operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Temperature at Time 15 Min	35.93 Degrees Celsius Standard Deviation 0.44	35.87 Degrees Celsius Standard Deviation 0.30	36.14 Degrees Celsius Standard Deviation 0.39

SECONDARY outcome

Timeframe: Intraoperative

Temperature in degrees Celsius at 30 min during operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Temperature at Time 30 Min	35.99 Degrees Celsius Standard Deviation 0.48	35.93 Degrees Celsius Standard Deviation 0.29	36.18 Degrees Celsius Standard Deviation 0.33

SECONDARY outcome

Timeframe: Intraoperative

Temperature in degrees Celsius at 45 min during operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Temperature at Time 45 Min	36.03 Degrees Celsius Standard Deviation 0.51	36.09 Degrees Celsius Standard Deviation 0.36	36.42 Degrees Celsius Standard Deviation 0.22

SECONDARY outcome

Timeframe: Intraoperative

Temperature in degrees Celsius at 60 min during operative procedure

Outcome measures

Measure	ARM 1 n=14 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Temperature at Time 60 Min	36.19 Degrees Celsius Standard Deviation 0.52	36.05 Degrees Celsius Standard Deviation 0.30	36.20 Degrees Celsius Standard Deviation 0.40

SECONDARY outcome

Timeframe: Intraoperative

End-Tidal CO2 leve; recorded at 0 min during the operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
End-Tidal CO2 Level at Time 0	35.4 Percent CO2 Standard Deviation 3.0	35.1 Percent CO2 Standard Deviation 2.6	33.6 Percent CO2 Standard Deviation 2.0

SECONDARY outcome

Timeframe: Intraoperative

End-Tidal CO2 level recorded at 15 min during the operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
End-Tidal CO2 Level at Time 15	35.7 Percent CO2 Standard Deviation 3.7	36.1 Percent CO2 Standard Deviation 2.4	34.2 Percent CO2 Standard Deviation 1.3

SECONDARY outcome

Timeframe: Intraoperative

End-Tidal CO2 level recorded at 30 min during the operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
End-Tidal CO2 Level at Time 30	35.1 Percent CO2 Standard Deviation 4.2	35.8 Percent CO2 Standard Deviation 3.4	34.0 Percent CO2 Standard Deviation 1.0

SECONDARY outcome

Timeframe: Intraoperative

End-Tidal CO2 level recorded at 45 min during the operative procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
End-Tidal CO2 Level at Time 45	35.9 Percent CO2 Standard Deviation 2.8	35.4 Percent CO2 Standard Deviation 3.5	35.4 Percent CO2 Standard Deviation 1.7

SECONDARY outcome

Timeframe: Intraoperative

End-Tidal CO2 level recorded at 60 min during the operative procedure

Outcome measures

Measure	ARM 1 n=14 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
End-Tidal CO2 Level at Time 60	36.1 Percent CO2 Standard Deviation 3.1	35.0 Percent CO2 Standard Deviation 2.8	35.8 Percent CO2 Standard Deviation 1.6

SECONDARY outcome

Timeframe: Intraoperative

Time from placement of last surgical port to colpotomy (hysterectomy) or closure of last uterine defect (myomectomy)

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Duration of Procedure	40.5 Minutes Standard Deviation 20.8	46.9 Minutes Standard Deviation 18.3	56.8 Minutes Standard Deviation 31.5

SECONDARY outcome

Timeframe: 2 weeks following procedure completion

The number of participants with a hospital duration of stay less than 24 hours recorded as "yes" or "no." Data represent the number of participants with a hospital stay less than 24 hours.

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Number of Participants With a Hospital Stay Less Than 24 Hours	15 Participants	15 Participants	5 Participants

SECONDARY outcome

Timeframe: Before hospital discharge

Post operative pain evaluated according to a numerical rating scale from 0 (no pain) to 10 (worst pain possible)

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Postoperative Pain Numerical Rating Scale	2.7 score on a scale Standard Deviation 2.4	2.7 score on a scale Standard Deviation 1.8	2.8 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 2 weeks following procedure completion

Post operative pain evaluated according to a numerical rating scale from 0 (no pain) to 10 (worst pain possible)

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Postoperative Pain Numerical Rating Scale	0.7 score on a scale Standard Deviation 2.3	0.1 score on a scale Standard Deviation 0.5	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Post-operative hospitalization

The number of participants that received post-operative opioid pain medication during hospital stay recorded as "yes" or "no." Data represent the number of participants that received post-operative opioid pain medication during hospital stay.

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Number of Participants That Received Post-operative Opioid Pain Medication	12 Participants	12 Participants	5 Participants

SECONDARY outcome

Timeframe: Post-operative hospitalization

The number of participants that received post-operative non-opioid pain medication during hospital stay recorded as "yes" or "no." Data represent the number of participants that received post-operative non-opioid pain medication during hospital stay.

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Number of Participants That Received Post-operative Non-opioid Pain Medication	14 Participants	14 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 week follow up visit

The number of participants that reported opioid pain medication use at follow up visit recorded as "yes" or "no." Data represent the number of participants that reported opioid pain medication use at follow up.

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Number of Participants Reporting Opioid Pain Medication Use at Follow up	10 Participants	7 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 week follow up visit

The number of participants that reported non-opioid pain medication use at follow up visit recorded as "yes" or "no." Data represent the number of participants that reported non-opioid pain medication use at follow up.

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Number of Participants Reporting Non-opioid Pain Medication Use at Follow up	10 Participants	9 Participants	1 Participants

SECONDARY outcome

Timeframe: Intraoperative up to 2 weeks post procedure

Number of subjects with adverse events determined probably related or related to procedure

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Adverse Events Related to Procedure	5 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Intraoperative up to 2 week follow up visit

Number of subjects with adverse events determined probably related or related to smoke clearing device

Outcome measures

Measure	ARM 1 n=15 Participants Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 Participants Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 Participants Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Adverse Events Related to Smoke Clearing Device	0 Participants	0 Participants	0 Participants

Adverse Events

ARM 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ARM 2

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

ARM 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ARM 1 n=15 participants at risk Laparoscopic hysterectomy with use of the Ultravision System Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.	ARM 2 n=15 participants at risk Laparoscopic Hysterectomy per Standard of Care/no Ultravision System Laparoscopic Hysterectomy: Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System	ARM 3 n=5 participants at risk Laparoscopic myomectomy with use of the Ultravision System. Ultravision System: Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
Renal and urinary disorders Urinary retention	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Reproductive system and breast disorders Vaginal bleeding	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Psychiatric disorders Mood changes	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Nervous system disorders Bell's Palsy	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Gastrointestinal disorders Constipation	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Reproductive system and breast disorders Vaginal pruritus	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Surgical and medical procedures Breast Surgery	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Surgical and medical procedures Bladder Perforation	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Reproductive system and breast disorders Ovarian mass	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	13.3% 2/15 • Number of events 2 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.
Reproductive system and breast disorders Endometriosis lesion	0.00% 0/15 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	6.7% 1/15 • Number of events 1 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.	0.00% 0/5 • Adverse event data was collected from screening/baseline through the 2-week follow up visit.

Additional Information

David Levine, MD

Mercy Hospital St. Louis

Phone: 314-251-7650

Email: David.Levine@Mercy.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place