A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/16/2018 |
| Start Date: | January 2003 |
| End Date: | September 2014 |
A Comparative Study of the Physiological Response, Between AirSeal, an Integrated Insufflation and Access System, and Conventional Insufflation and Trocars
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.
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.
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
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
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
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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