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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
NOT_YET_RECRUITINGSwedish Medical Center
Seattle, Washington, United States
RECRUITINGRate of insufflation device related subcutaneous emphysema (SCE) at 2 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Time frame: 2 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Time frame: 4 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Time frame: 8 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Time frame: 12 hours post procedure
Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours
Rate of insufflation device related subcutaneous emphysema(SCE)
Time frame: 24 hours post procedure
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
Time frame: 2, hours post procedure
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
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Time frame: 4 hours post procedure
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
Time frame: 8 hours post procedure
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
Time frame: 12 hours post procedure
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
Time frame: 24 hours post procedure