Trial Outcomes & Findings for A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation (NCT NCT02075658)
NCT ID: NCT02075658
Last Updated: 2018-02-14
Results Overview
Our primary aim is to show reduction in the variance of intra-abdominal pressure throughout the operative procedure when using the AirSeal device compared to a conventional insufflator. Based on preliminary data, we assume pressures maintained at a mean of 15 through out surgery for both devices and a variance of 3.6 with the conventional insufflator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Day 1 (Day of Procedure)
Results posted on
2018-02-14
Participant Flow
Competent adults (\>18 years old)(male or female) undergoing laparoscopic/robotic renal or peri-renal procedures will be included in this study.
Participant milestones
| Measure |
Conventional Insufflation and Trocars
Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.
Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
|
AirSeal® System-Interventional
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).
AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Conventional Insufflation and Trocars
Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.
Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
|
AirSeal® System-Interventional
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).
AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
2
|
Baseline Characteristics
A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation
Baseline characteristics by cohort
| Measure |
Conventional Insufflation and Trocars
n=28 Participants
Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.
Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
|
AirSeal® System-Interventional
n=28 Participants
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).
AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 28.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/PI
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
|
3.2 units on a scale (0-43)
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.6 units on a scale (0-43)
STANDARD_DEVIATION 2.4 • n=7 Participants
|
3.4 units on a scale (0-43)
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Treatment
Radical Nephrectomy
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Treatment
Simple Nephrectomy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Treatment
Partial Nephrectomy
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Treatment
Nephroureterectomy
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Treatment
Cryoablation
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Treatment
Pyeloplasty
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Treatment
Ureteral implantation
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Treatment
Retroperitoneal mass excision
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Day of Procedure)Our primary aim is to show reduction in the variance of intra-abdominal pressure throughout the operative procedure when using the AirSeal device compared to a conventional insufflator. Based on preliminary data, we assume pressures maintained at a mean of 15 through out surgery for both devices and a variance of 3.6 with the conventional insufflator.
Outcome measures
| Measure |
Conventional Insufflation and Trocars
n=28 Participants
Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.
Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
|
AirSeal® System-Interventional
n=28 Participants
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).
AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal.
|
|---|---|---|
|
AirSeal Reduction in the Variance of Intra-abdominal Pressure
|
5.5 mmHg
Standard Deviation 3.3
|
1.3 mmHg
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Day 1 (Day of Procedure)Assuming cardiac output of approximately 5.0 L/min with the conventional device, we will have 96% power to detect as significant an improvement in cardiac output to 5.5 L/min using a two-group Satterwaite t-test and assuming variance of 0.25. Cardiac out put is defined by the volume of blood pumped by the heart in a given amount of time.
Outcome measures
| Measure |
Conventional Insufflation and Trocars
n=28 Participants
Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center.
Conventional Insufflator and Trocar: Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
|
AirSeal® System-Interventional
n=28 Participants
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port).
AirSeal® System-Interventional: The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal.
|
|---|---|---|
|
Improvement in Cardiac Output With the AirSeal Device.
|
NA volume per minute
Standard Deviation NA
Current staff is unable to locate the analysed data from the original study and only has the published article to go by. We do not have the mean and standard deviation for this outcome measure. We only have the interpreted results from the paper.
|
NA volume per minute
Standard Deviation NA
Current staff is unable to locate the analysed data from the original study and only has the published article to go by. We do not have the mean and standard deviation for this outcome measure. We only have the interpreted results from the paper.
|
Adverse Events
Conventional Insufflation and Trocars
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AirSeal® System-Interventional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Coordinator
UCI Health Department of Urology
Phone: 714-456-8176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place