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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: Completed NA study, sponsored by University of California, Irvine.
NCT02075658 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT02075658 record still lists
NCT02075658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which AirSeal® System-Interventional is the first listed.
NCT02075658 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02075658's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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