Clinical trial NCT02262884: SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)
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
Overall status: UNKNOWN
Phase: NA
Conditions: Subcutaneous Emphysema
Lead sponsor: SurgiQuest, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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Primary outcomes:
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
timeFrame: 2 hours post procedure
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
timeFrame: 4 hours post procedure
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
timeFrame: 8 hours post procedure
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
timeFrame: 12 hours post procedure
measure: Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
timeFrame: 24 hours post procedure
Secondary outcomes:
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
timeFrame: 2, hours post procedure
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
timeFrame: 4 hours post procedure
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
timeFrame: 8 hours post procedure
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
timeFrame: 12 hours post procedure
measure: Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)
timeFrame: 24 hours post procedure
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center, Seattle , WA
name: James Porter, MD
role: PRINCIPAL_INVESTIGATOR
References: