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

NCT02075658 · University of California, Irvine · Updated 14 Feb 2018

What is being tested
AirSeal® System-Interventional; Conventional Insufflator and Trocar
For
Renal Cell Carcinoma
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 60 people. The full rules are on the registry page.
Where
United States
When
Starts or started Jan 2003, ends Sept 2014. Registered 3 March 2014.
Results
Posted on the registry on 14 Feb 2018.

In the researchers' words

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…
ClinicalTrials.gov, NCT02075658

Sites

  • University of California, Irvine Medical CenterOrange, California, United States