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NCT02075658 · ClinicalTrials.gov registry record · NA
A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT02075658 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 60 participants.
The verdict
NCT02075658, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DEVICE AirSeal® System-Interventional
- DEVICE Conventional Insufflator and Trocar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2003-01 |
| Est. Completion | 2014-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02075658
The ClinicalTrials.gov registry entry for NCT02075658 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AirSeal® System-Interventional is the first listed.
NCT02075658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02075658 about?
NCT02075658 is a clinical study titled "A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation". 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 cance...
What is the current status of trial NCT02075658?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2003-01. Estimated completion is 2014-09.
What interventions are being tested in trial NCT02075658?
The interventions under investigation include: AirSeal® System-Interventional (DEVICE), Conventional Insufflator and Trocar (DEVICE).
Who is sponsoring clinical trial NCT02075658?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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