Recruiting

AirSeal

Sponsor:

SurgiQuest, Inc.

Code:

NCT02262884

Conditions

Subcutaneous Emphysema

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SurgiQuest AirSeal Insufflation System (AIS)

Conventional Insufflation System (CIS)

Study Details

Brief summary:

A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE PHYSICIAN PREFERENCE RELATED TO THE USE OF THE SURGIQUEST AIRSEAL INSUFFLATION SYSTEM (AIS) VS. CONVENTIONAL INSUFFLATION SYSTEMS (CIS) FOR THE MANAGEMENT OF PNEUMOPERITONEUM DURING ROBOTIC PARTIAL NEPHRECTOMY

Conditions

Subcutaneous Emphysema

Study ID

NCT02262884

Start date

Oct, 2014

Status verified date

Jun, 2016

Completion date

Mar, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;

Exclusion Criteria:

Subjects will be excluded from participating in this Study if they meet any of the following criteria prior to initiation of the endoscopic procedure 1.Advanced refusal of blood transfusion, if necessary; 2.Active systemic or cutaneous infection or inflammation; 3 Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4.Uncontrolled diabetes mellitus 5.Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 6.Severe co-existing morbidities having a life expectancy of less than 30 days; 7.Currently involved in any other investigational clinical Studies; 8.Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 9.Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 10.Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); 11. Patients presenting with Ascites

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Study Design

Enrollment

189 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: AIS @ 12mmHg pressure

SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.

active comparator: AIS @ 15mmHg pressure

SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.

active comparator: CIS @ 15mmHg pressure

Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy.

Interventions

SurgiQuest AirSeal Insufflation System (AIS)

Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.

Conventional Insufflation System (CIS)

Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.

Primary outcome measure

  • Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours [ Time Frame: 2 hours post procedure ]
  • Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours [ Time Frame: 4 hours post procedure ]
  • Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours [ Time Frame: 8 hours post procedure ]
  • Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours [ Time Frame: 12 hours post procedure ]
  • Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours [ Time Frame: 24 hours post procedure ]

Central Contacts and Locations

Central contacts

Locations

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Aleksandra Klim, RN MHS CCRC

314-747-9781klima@wudosis.wustl.edu

Principal Investigator:

Robert Figenshau, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

More Information

Sponsor

SurgiQuest, Inc.

Last update posted

Jun 6, 2016

Last verified

Jun, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SurgiQuest, Inc. on 2016-06-06.