search
Back to results

SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study) (TARPAN)

Primary Purpose

Subcutaneous Emphysema

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SurgiQuest AirSeal Insufflation System (AIS)
Conventional Insufflation System (CIS)
Sponsored by
SurgiQuest, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subcutaneous Emphysema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Washington University School of MedicineRecruiting
  • Hackensack University Medical Center
  • Swedish Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

AIS @ 12mmHg pressure

AIS @ 15mmHg pressure

CIS @ 15mmHg pressure

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
Rate of insufflation device related subcutaneous emphysema(SCE)

Secondary Outcome Measures

Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication

Full Information

First Posted
September 30, 2014
Last Updated
June 2, 2016
Sponsor
SurgiQuest, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02262884
Brief Title
SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)
Acronym
TARPAN
Official Title
A Physician Preference Study of the Use of SurgiQuest AirSeal vs. Conventional Insufflation Systems for the Management of Pneumoperitoneum in Robotic Partial Nephrectomy .
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SurgiQuest, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subcutaneous Emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AIS @ 12mmHg pressure
Arm Type
Active Comparator
Arm Description
SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.
Arm Title
AIS @ 15mmHg pressure
Arm Type
Active Comparator
Arm Description
SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.
Arm Title
CIS @ 15mmHg pressure
Arm Type
Active Comparator
Arm Description
Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy.
Intervention Type
Device
Intervention Name(s)
SurgiQuest AirSeal Insufflation System (AIS)
Intervention Description
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
Intervention Name(s)
Conventional Insufflation System (CIS)
Intervention Description
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 Information:
Title
Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
Description
Rate of insufflation device related subcutaneous emphysema(SCE)
Time Frame
2 hours post procedure
Title
Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
Description
Rate of insufflation device related subcutaneous emphysema(SCE)
Time Frame
4 hours post procedure
Title
Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
Description
Rate of insufflation device related subcutaneous emphysema(SCE)
Time Frame
8 hours post procedure
Title
Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
Description
Rate of insufflation device related subcutaneous emphysema(SCE)
Time Frame
12 hours post procedure
Title
Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
Description
Rate of insufflation device related subcutaneous emphysema(SCE)
Time Frame
24 hours post procedure
Secondary Outcome Measure Information:
Title
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Description
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Time Frame
2, hours post procedure
Title
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Description
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Time Frame
4 hours post procedure
Title
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Description
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Time Frame
8 hours post procedure
Title
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Description
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Time Frame
12 hours post procedure
Title
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
Description
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication
Time Frame
24 hours post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 80 years of age; Capable and willing to give informed consent; 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cynthia Harris, BS
Phone
775-392-2970
Email
cindy@clinregconsult.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Daniel, BS,MS,MBA
Phone
775-392-2970
Email
MADaniel@clinregconsult.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Porter, MD
Organizational Affiliation
Swedish Medical Center, Seattle , WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandra Klim, RN MHS CCRC
Phone
314-747-9781
Email
klima@wudosis.wustl.edu
First Name & Middle Initial & Last Name & Degree
Robert Figenshau, MD
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cheryl Fittizzi
Phone
551-996-2255
Email
CFittizzi@HackensackUMC.org
First Name & Middle Initial & Last Name & Degree
Michael Stifelman, MD
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Algren, RN
Phone
206-386-2820
Email
heather.algren@swedish.org
First Name & Middle Initial & Last Name & Degree
Adel Islam
Phone
(206) 215-6532
Email
adel.islam@swedish.org

12. IPD Sharing Statement

Learn more about this trial

SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)

We'll reach out to this number within 24 hrs