SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study) (TARPAN)
Subcutaneous Emphysema
About this trial
This is an interventional treatment trial for Subcutaneous Emphysema
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
-
Sites / Locations
- Washington University School of MedicineRecruiting
- Hackensack University Medical Center
- Swedish Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
AIS @ 12mmHg pressure
AIS @ 15mmHg pressure
CIS @ 15mmHg pressure
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.