A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02075658
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 140
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Renal cancer has traditionally been treated by surgical removal of the tumor, as the tumors are resistant to chemotherapy and radiation. The traditional treatment, where the entire kidney and tumor were removed through an abdominal incision, may now have more long term problems than the actual cancer. As a result, less invasive techniques have been developed such as laparoscopic surgery where the abdomen is inflated with carbon dioxide (i.e. via an insufflation system) and the surgery performed with special instruments through small ports, known as trocars. Rapid advances in minimally invasive surgical techniques demand ongoing technological improvement.

Conventional insufflators and trocars allow for laparoscopic surgery to occur, however the system does not account for pressure changes within the abdomen when instruments are inserted or removed. The AirSeal® System consisting of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port) has been designed to create and maintain the pressure barrier throughout the procedure. The objective of this study is to collect comparative physiological, pulmonary compliance and surgical utility data for both the AirSeal® System and conventional insufflators and trocars in a controlled population undergoing laparoscopic/robotic renal or peri-renal procedures. Subjects enrolled in this study will have their procedure performed using either the AirSeal® System or a conventional insufflator and trocars. Both systems have been cleared for use by the FDA's 510(k) process and are currently employed in clinical practice, including at University of California, Irvine Medical Center. We hypothesize that with the use of the AirSeal® System, laparoscopic efficiencies and outcomes will be significantly greater than with the conventional insufflator and trocars system.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Device: AirSeal® System-Interventional; Device: Conventional Insufflator and Trocar	N/A

Detailed Description

Rapid advances in minimally invasive surgical techniques demand ongoing technological improvement.

The benefits of laparoscopic surgery to patient comfort and recovery have been made with procedures such as the cholecystectomy and gastric bypass. 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. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® IFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier. The AirSeal® System has applications in abdominal minimally invasive surgical procedures to establish a path of entry for laparoscopic instruments. The insufflation and recirculation system (AirSeal® IFS) is reusable and the AirSeal® Access Port and triple lumen filtered tube set are designed as single patient use devices. The 1st generation AirSeal® System received FDA 510(k) clearance in 2007 and the current system received FDA 510(k) Clearance in May 2011. Since that time, the AirSeal™ system has been used routinely in centers throughout the United States and has been observed by surgeons and anesthesia teams to provide a more gentle, stable, and consistent pneumoperitoneum. Initial evidence of this has reported in the literature1. Kavoussi and colleagues state; "We have found that patients had blunted end-tidal carbon dioxide (CO2) levels and CO2 elimination rates compared with the CO2 elimination rates observed in studies evaluating transperitoneal laparoscopy using the conventional trocar. To determine if a difference truly exists, CO2 elimination rates must be prospectively analyzed in a head to head comparison between valve-less and conventional trocars." This study is designed to compare the physiological impact and pulmonary compliance of patients undergoing laparoscopic/robotic renal or peri-renal surgery with and without the AirSeal® System.

1 A new Valve-Less Trocar for Urology Laparoscopy: Initial Evaluation. Journal of Endourology 2009;23: 1535-39

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Comparative Study of the Physiological Response, Between AirSeal, an Integrated Insufflation and Access System, and Conventional Insufflation and Trocars
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: 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).
Active Comparator: 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).	Device: 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.

Outcome Measures

Primary Outcome Measures

1. AirSeal Reduction in the Variance of Intra-abdominal Pressure [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.

Secondary Outcome Measures

1. Improvement in Cardiac Output With the AirSeal Device. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Competent adult (18 years of age and older) males and females.

2. Persons undergoing laparoscopic/robotic renal or peri-renal procedures.

Exclusion criteria:

1. Under age 18

2. Unable to provide informed consent

3. Have a history of ascites

4. History of transplant kidney

5. Solitary kidney (one kidney)

6. Uncontrolled Diabetes (HbA1c > 8)

7. Pregnancy (as noted by standard of care history and physical)

8. Women who are breast-feeding

9. History of narcotic abuse or chronic pain

10. Emergency Surgery

11. Person's participating in any other research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: Jaime Landman, MD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaime Landman, Professor of Urology and Radiology Chairman, Department of Urology, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT02075658
• Other Study ID Numbers: 2012-9088
• First Posted: Mar 3, 2014
• Last Update Posted: Feb 14, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jaime Landman, Professor of Urology and Radiology Chairman, Department of Urology, University of California, Irvine: renal cell carcinoma; minimally invasive procedures; robotic nephrectomy; laparoscopic nephrectomy; pneumoperitoneum; trocars; AirSeal® IFS
• Additional relevant MeSH terms: Carcinoma, Renal Cell

Study Results

Participant Flow

Pre-assignment Detail	Competent adults (>18 years old)(male or female) undergoing laparoscopic/robotic renal or peri-renal procedures will be included in this study.

Arm/Group Title	Conventional Insufflation and Trocars	AirSeal® System-Interventional
Arm/Group Description	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).	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.
Period Title: Overall Study
STARTED	30	30
COMPLETED	28	28
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Conventional Insufflation and Trocars	AirSeal® System-Interventional	Total
Arm/Group Description	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).	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 of all reporting groups
Overall Participants	28	28	56
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.8 (13.1)	62.5 (15.3)	63.7 (28.3)
Sex: Female, Male (Count of Participants)
Female	10 35.7%	5 17.9%	15 26.8%
Male	18 64.3%	23 82.1%	41 73.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 7.1%	1 3.6%	3 5.4%
Not Hispanic or Latino	26 92.9%	27 96.4%	53 94.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	24 85.7%	22 78.6%	46 82.1%
Black	1 3.6%	1 3.6%	2 3.6%
Asian	1 3.6%	2 7.1%	3 5.4%
Hawaiian/PI	0 0%	1 3.6%	1 1.8%
Other	2 7.1%	2 7.1%	4 7.1%
Charlson Comorbidity Index (units on a scale (0-43)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale (0-43)]	3.2 (1.7)	3.6 (2.4)	3.4 (2.1)
Treatment (Count of Participants)
Radical Nephrectomy	8 28.6%	9 32.1%	17 30.4%
Simple Nephrectomy	1 3.6%	0 0%	1 1.8%
Partial Nephrectomy	11 39.3%	9 32.1%	20 35.7%
Nephroureterectomy	1 3.6%	3 10.7%	4 7.1%
Cryoablation	5 17.9%	4 14.3%	9 16.1%
Pyeloplasty	1 3.6%	2 7.1%	3 5.4%
Ureteral implantation	0 0%	1 3.6%	1 1.8%
Retroperitoneal mass excision	1 3.6%	0 0%	1 1.8%

Outcome Measures

1. Primary Outcome

Title	AirSeal Reduction in the Variance of Intra-abdominal Pressure
Description	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.
Time Frame	Day 1 (Day of Procedure)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Insufflation and Trocars	AirSeal® System-Interventional
Arm/Group Description	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).	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.
Measure Participants	28	28
Mean (Standard Deviation) [mmHg]	5.5 (3.3)	1.3 (1.1)

2. Secondary Outcome

Title	Improvement in Cardiac Output With the AirSeal Device.
Description	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.
Time Frame	Day 1 (Day of Procedure)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Insufflation and Trocars	AirSeal® System-Interventional
Arm/Group Description	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).	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.
Measure Participants	28	28
Mean (Standard Deviation) [volume per minute]	NA (NA)	NA (NA)

Adverse Events

Arm/Group Title	Conventional Insufflation and Trocars		AirSeal® System-Interventional
Arm/Group Description	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).		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.
All Cause Mortality
	Conventional Insufflation and Trocars		AirSeal® System-Interventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Conventional Insufflation and Trocars		AirSeal® System-Interventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Conventional Insufflation and Trocars		AirSeal® System-Interventional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.