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

Renal Cell Carcinoma Clinical Trial

Official title:

A Comparative Study of the Physiological Response, Between AirSeal, an Integrated Insufflation and Access System, and Conventional Insufflation and Trocars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075658
• Other study ID #: 2012-9088
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: January 16, 2018
• Start date: January 2003
• Est. completion date: September 2014

Study information

• Verified date: January 2018
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bucur P, Hofmann M, Menhadji A, Abedi G, Okhunov Z, Rinehart J, Landman J. Comparison of Pneumoperitoneum Stability Between a Valveless Trocar System and Conventional Insufflation: A Prospective Randomized Trial. Urology. 2016 Aug;94:274-80. doi: 10.1016/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AirSeal Reduction in the Variance of Intra-abdominal Pressure	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.	Day 1 (Day of Procedure)
Secondary	Improvement in Cardiac Output With the AirSeal Device.	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.	Day 1 (Day of Procedure)