Status:
UNKNOWN
SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)
Lead Sponsor:
SurgiQuest, Inc.
Conditions:
Subcutaneous Emphysema
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 In...
Eligibility Criteria
Inclusion
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent robotic partial nephrectomy;
Exclusion
- 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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Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT02262884
Start Date
October 1 2014
End Date
March 1 2017
Last Update
June 6 2016
Active Locations (3)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Swedish Medical Center
Seattle, Washington, United States, 98122