Trial Outcomes & Findings for Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for Endometriosis (NCT NCT03956082)
NCT ID: NCT03956082
Last Updated: 2022-11-17
Results Overview
The ability to complete the procedure without increasing pneumoperitoneum due to visualization. Any increase beyond 10mm Hg and the reason for change will be recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Intraoperative
Results posted on
2022-11-17
Participant Flow
Participant milestones
| Measure |
This is a Prospective Single Arm Study
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
This is a Prospective Single Arm Study
n=9 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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Age, Customized
Age of participants
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28 years
n=9 Participants
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Sex/Gender, Customized
Women
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9 Participants
n=9 Participants
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Region of Enrollment
United States
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9 participants
n=9 Participants
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Body Mass Index (BMI)
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24.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=9 Participants
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Endometriosis diagnoses
Pelvic pain
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4 Participants
n=9 Participants
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Endometriosis diagnoses
Ovarian cyst
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2 Participants
n=9 Participants
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Endometriosis diagnoses
Other (diagnoses included menorrhagia, hematochezia and dysmenorrhea and dyspareunia)
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3 Participants
n=9 Participants
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Indicated pain location on representative human figure
Not applicable
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5 Participants
n=9 Participants
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Indicated pain location on representative human figure
Lower abdomen
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2 Participants
n=9 Participants
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Indicated pain location on representative human figure
Left lower quadrant (LLQ)
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1 Participants
n=9 Participants
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Indicated pain location on representative human figure
Right lower quadrant (RLQ)
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1 Participants
n=9 Participants
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Pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).
Pain score of 0
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5 Participants
n=9 Participants
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Pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).
Pain score of 1
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2 Participants
n=9 Participants
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Pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).
Pain score of 2
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1 Participants
n=9 Participants
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Pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).
Pain score of 3
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1 Participants
n=9 Participants
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Recorded name, dose and frequency of any pain medication taken within 24 hours of surgical procedure
Taking "1/2 pill" Percocet (class 4 drug) (not prescribed) prn for pain within 24 of surgery.
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1 Participants
n=9 Participants
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Recorded name, dose and frequency of any pain medication taken within 24 hours of surgical procedure
Taking 600mg ibuprofen (class 2 drug) prn for pain within 24 of surgery.
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1 Participants
n=9 Participants
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Recorded name, dose and frequency of any pain medication taken within 24 hours of surgical procedure
Not taking pain medication within 24 hours of surgery.
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5 Participants
n=9 Participants
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Recorded name, dose and frequency of any pain medication taken within 24 hours of surgical procedure
Unspecified pain medication for unrelated condition(s)
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2 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: IntraoperativeThe ability to complete the procedure without increasing pneumoperitoneum due to visualization. Any increase beyond 10mm Hg and the reason for change will be recorded.
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=9 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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Procedure Completed Without Change in Intra-abdominal Pressure
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9 Participants
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PRIMARY outcome
Timeframe: Intra-operativeThe quality of visualization in the laparoscopic field of view will be assessed by the investigator using a Visual Analog Scale (VAS). The scale will rate the overall quality of visualization during the procedure on a scale numbered 0 to 100, in increments of 10, where 0 equals poor and 100 equals excellent.
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=9 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Quality of Visualization Laparoscopic Field
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100 score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: A mean of 31 days (SD=2.8) after surgical procedurePatient satisfaction in post-surgical cosmesis outcome, administered via telephone, assessed by means of a survey scaled from 1 - 7, where 1 = "very unsatisfied" and 7 = "very satisfied".
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=9 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Cosmesis Outcome
5
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1 Participants
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Cosmesis Outcome
6
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2 Participants
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Cosmesis Outcome
7
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6 Participants
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SECONDARY outcome
Timeframe: Day 1-7 postoperativePopulation: The pain diary for post-operative days 1-7 was completed by eight of the nine subjects.
Patient shoulder postoperative pain assessments. Recorded by the patient each day from day 1 to day 7 postoperative using a 10 Numerical Rating Scale (NRS) where 0 is "no pain at all" to 10 "worst pain imaginable".
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=8 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 1
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3.125 score on a scale
Interval 0.0 to 7.0
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 2
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1.25 score on a scale
Interval 0.0 to 5.0
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 3
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0.5 score on a scale
Interval 0.0 to 2.0
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 4
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0.625 score on a scale
Interval 0.0 to 3.0
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 5
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0.25 score on a scale
Interval 0.0 to 2.0
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 6.
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0.125 score on a scale
Interval 0.0 to 1.0
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Postoperative Shoulder Pain Assessment (Day 1-7)
Post-operative day 7
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0 score on a scale
Interval 0.0 to 0.0
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SECONDARY outcome
Timeframe: Day 1-7 postoperativePopulation: The pain diary for post-operative days 1-7 was completed by eight of the nine subjects.
Some subjects recorded taking opioid and non-opioid medications for pain. Non-opioid medications included non-steroidal anti-inflammatory drugs and acetaminophen.
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=8 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 1
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5 Participants
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 2
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3 Participants
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 3
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0 Participants
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 4
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0 Participants
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 5
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0 Participants
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 6
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0 Participants
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Opioid/Opioid-containing Medication Taken Postoperatively for Pain
Post-operative day 7
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1 Participants
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SECONDARY outcome
Timeframe: Day 1-7 postoperativePopulation: The pain diary for post-operative days 1-7 was completed by eight of the nine subjects.
Patient postoperative abdominal pain assessments. Recorded by the patient each day from day 1 to day 7 postoperative using a 10 Numerical Rating Scale (NRS) where 0 is "no pain at all" to 10 "worst pain imaginable".
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=8 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 1
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3.125 score on a scale
Interval 0.0 to 6.0
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 2
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3.75 score on a scale
Interval 1.0 to 6.0
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 3
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3 score on a scale
Interval 1.0 to 5.0
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 4
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2.75 score on a scale
Interval 1.0 to 6.0
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 5
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2.25 score on a scale
Interval 1.0 to 4.0
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 6
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1.6875 score on a scale
Interval 0.0 to 7.5
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Postoperative Abdominal Pain Assessment (Day 1-7)
Post-operative day 7
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1.375 score on a scale
Interval 0.0 to 3.0
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SECONDARY outcome
Timeframe: Day 1-7 postoperativePopulation: The pain diary for post-operative days 1-7 was completed by eight of the nine subjects.
Some subjects recorded taking opioid and non-opioid medications for pain. Non-opioid medications included non-steroidal anti-inflammatory drugs and acetaminophen.
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=8 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 1
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6 Participants
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 2
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7 Participants
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 3
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5 Participants
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 4
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6 Participants
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 5
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4 Participants
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 6
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3 Participants
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Non-opioid Medication Taken Postoperatively for Pain
Post-operative day 7
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3 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeEnd tidal CO2 volume (etCO2) taken at the start of the procedure and at the end of the procedure (trocar removal).
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=9 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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End Tidal CO2 Volume
At the beginning of the procedure.
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32.1 mm Hg
Standard Deviation 3.1
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End Tidal CO2 Volume
At the end of the procedure.
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35.2 mm Hg
Standard Deviation 2.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedureEstimate of case complexity/difficulty will be recorded using a Visual Analog Scale (VAS) indicating how often smoke management was a factor during the procedure on a scale ranging from 1 - 100, where 1 was "Often" and 100 was "Never".
Outcome measures
| Measure |
This is a Prospective Single Arm Study
n=9 Participants
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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|---|---|
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Case Complexity
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100 score on a scale
Standard Deviation 0
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Adverse Events
This is a Prospective Single Arm Study
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
This is a Prospective Single Arm Study
n=9 participants at risk
The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.
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
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Injury, poisoning and procedural complications
Shoulder pain
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55.6%
5/9 • Number of events 14 • 2 weeks
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Injury, poisoning and procedural complications
Abdominal pain
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100.0%
9/9 • Number of events 60 • 2 weeks
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Injury, poisoning and procedural complications
Pain at unspecified location
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22.2%
2/9 • Number of events 2 • 2 weeks
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place