Renal Cell CarcinomaNCT02075658
A Comparative Study Between AirSeal, an Integrated Insufflation System, and Conventional Insufflation
A study testing AirSeal® System-Interventional and Conventional Insufflator and Trocar in people with Renal Cell Carcinoma, run by University of California, Irvine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- AirSeal® System-Interventional and Conventional Insufflator and Trocar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent adult (18 years of age and older) males and females.
- Persons undergoing laparoscopic/robotic renal or peri-renal procedures.
Who cannot join
- Under age 18
- Unable to provide informed consent
- Have a history of ascites
- History of transplant kidney
- Solitary kidney (one kidney)
- Uncontrolled Diabetes (HbA1c > 8)
Show all 11Show fewer
- Pregnancy (as noted by standard of care history and physical)
- Women who are breast-feeding
- History of narcotic abuse or chronic pain
- Emergency Surgery
- Person's participating in any other research
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
Official title: 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.
Read the detailed 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
- Conditions
- Renal Cell Carcinoma
- Being tested
- AirSeal® System-Interventional, Conventional Insufflator and Trocar
- Keywords
- renal cell carcinoma, minimally invasive procedures, robotic nephrectomy, laparoscopic nephrectomy, pneumoperitoneum, trocars, AirSeal® IFS
- Medical subject headings
- Carcinoma, Renal Cell, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSeal® System-InterventionalDevice
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 TrocarDevice
Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Insufflation and Trocars | Other | Subjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center. Receives: Device: Conventional Insufflator and Trocar |
| AirSeal® System-Interventional | Active comparator | 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). Receives: Device: AirSeal® System-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (Day of Procedure)
Secondary outcomes (1)
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.
Measured: Day 1 (Day of Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJan 2003
- Primary completionMar 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Landman, University of California, Irvine
- Investigators
- Jaime Landman, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075658
- Sponsor's protocol ID
- 2012-9088
- Status last verified
- Jan 2018
- First submitted
- 1 Nov 2013
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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/j.urology.2016.04.022. Epub 2016 Apr 27.
PubMed 27130263
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Physiological Response, Between AirSeal, an Integrated Insufflation and Access System, and Conventional Insufflation and Trocars
- ClinicalTrials.gov ID
- NCT02075658
- Acronym / sponsor ID
- 2012-9088
- Conditions
- Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, minimally invasive procedures, robotic nephrectomy, laparoscopic nephrectomy, pneumoperitoneum, trocars, AirSeal® IFS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Insufflation and Trocars | Other | Device: Conventional Insufflator and TrocarSubjects enrolled in this study arm will have their procedure performed using either the conventional insufflator and trocars. This system have been cleared for use by the FDA's 510 (k)process and are currently employed in clinical practice, including at UC Irvine Medical Center. |
| AirSeal® System-Interventional | Active comparator | Device: AirSeal® System-InterventionalThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Competent adult (18 years of age and older) males and females.
- Persons undergoing laparoscopic/robotic renal or peri-renal procedures.
Key exclusion criteria (11 listed)
- Under age 18
- Unable to provide informed consent
- Have a history of ascites
- History of transplant kidney
- Solitary kidney (one kidney)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirSeal® System-InterventionalThe 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. | Device | AirSeal® System-Interventional |
| Conventional Insufflator and TrocarConventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System). | Device | Conventional Insufflation and Trocars |
Primary outcome
AirSeal Reduction in the Variance of Intra-abdominal Pressure
Time frame: Day 1 (Day of Procedure)
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.
1 secondary outcome
Improvement in Cardiac Output With the AirSeal Device.
Time frame: Day 1 (Day of Procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27130263Bucur 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/j.urology.2016.04.022. Epub 2016 Apr 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Landman, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirSeal® System-Interventional and Conventional Insufflator and Trocar in people with Renal Cell Carcinoma, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AirSeal Reduction in the Variance of Intra-abdominal Pressure (time frame: Day 1 (Day of Procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.