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

NCT02075658 | Completed Results DMC

• 1 other identifier: 2012-9088
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

renal cell carcinoma; minimally invasive procedures; robotic nephrectomy; laparoscopic nephrectomy; pneumoperitoneum; trocars; AirSeal® IFS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in Cardiac Output With the AirSeal Device.

  Day 1 (Day of Procedure)

Study Arms (2)

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.

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).

Device: AirSeal® System-Interventional

Interventions

AirSeal® System-Interventional DEVICE

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.

AirSeal® System-Interventional

Conventional Insufflator and Trocar DEVICE

Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).

Conventional Insufflation and Trocars

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent adult (18 years of age and older) males and females.
• Persons undergoing laparoscopic/robotic renal or peri-renal procedures.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related 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/j.urology.2016.04.022. Epub 2016 Apr 27.

  PMID: 27130263 RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell; Pneumoperitoneum

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: UCI Health Department of Urology

yoonrh@uci.edu

714-456-8176

Study Officials

• Jaime Landman, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Radiology Chairman, Department of Urology

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: March 3, 2014
• Study Start: January 1, 2003
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 14, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)