SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)

Not Applicable

• Conditions: Subcutaneous Emphysema
• Interventions: Device: SurgiQuest AirSeal Insufflation System (AIS); Device: Conventional Insufflation System (CIS)

• Registration Number: NCT02262884
• Lead Sponsor: SurgiQuest, Inc.

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.

Study Timeline

• Study First Submitted: 2014-09-30
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-13
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-06
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIS @ 15mmHg pressure	SurgiQuest AirSeal Insufflation System (AIS)	SurgiQuest AirSeal insufflation System (AIS) set at 15 mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.
AIS @ 12mmHg pressure	SurgiQuest AirSeal Insufflation System (AIS)	SurgiQuest AirSeal Insufflation System (AIS) set at 12mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephrectomy.
CIS @ 15mmHg pressure	Conventional Insufflation System (CIS)	Conventional Insufflation System (CIS) set at 15mmHg pressure for the management of pneumoperitoneum during Robotic Partial Nephectomy.

Primary Outcome Measures

Name	Time	Method
Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours	2 hours post procedure	Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours	8 hours post procedure	Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours	4 hours post procedure	Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours	24 hours post procedure	Rate of insufflation device related subcutaneous emphysema(SCE)
Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours	12 hours post procedure	Rate of insufflation device related subcutaneous emphysema(SCE)

Secondary Outcome Measures

Name	Time	Method
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)	24 hours post procedure	Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication

Trial Locations

Locations (3)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States