SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)

NCT ID: NCT02262884

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-03-31

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

Detailed Description

A prospective, randomized, controlled multi-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSealTM Insufflation System (AIS) vs. Conventional Insufflation Systems (CIS) for the Management of pneumoperitoneum during Robotic Partial Nephrectomy. Subjects will be randomized in a 1:1:1 treatment device to control ratio into one of three (3) different study arms: 1) AIS @ 12mmHg pressure, 2) AIS @ 15mmHg pressure, and 3) CIS @ 15mmHg pressure. 189 randomized subjects distributed in three arms of 63 patients. The three study sites are targeted to enroll 63 patients each, 21 patients in each of the three (3) study arms. It is expected that this will take up to 6 months.

Conditions

Subcutaneous Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AIS @ 12mmHg pressure

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

Group Type: ACTIVE_COMPARATOR

SurgiQuest AirSeal Insufflation System (AIS)

Intervention Type: DEVICE

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

AIS @ 15mmHg pressure

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

Group Type: ACTIVE_COMPARATOR

SurgiQuest AirSeal Insufflation System (AIS)

Intervention Type: DEVICE

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

CIS @ 15mmHg pressure

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

Group Type: ACTIVE_COMPARATOR

Conventional Insufflation System (CIS)

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SurgiQuest, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Porter, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center, Seattle , WA

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status: NOT_YET_RECRUITING

Swedish Medical Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

cynthia Harris, BS

Role: CONTACT

cindy@clinregconsult.com

775-392-2970

Michael Daniel, BS,MS,MBA

Role: CONTACT

MADaniel@clinregconsult.com

775-392-2970

Facility Contacts

Aleksandra Klim, RN MHS CCRC

Role: primary

klima@wudosis.wustl.edu

314-747-9781

cheryl Fittizzi

Role: primary

CFittizzi@HackensackUMC.org

551-996-2255

Heather Algren, RN

Role: primary

heather.algren@swedish.org

206-386-2820

Adel Islam

Role: backup

adel.islam@swedish.org

(206) 215-6532

Other Identifiers

PRT DD112313

Identifier Type: -

Identifier Source: org_study_id