SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)

Subcutaneous Emphysema Clinical Trial

— TARPAN  

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 .

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02262884
• Other study ID #: PRT DD112313
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2014
• Last updated: June 2, 2016
• Start date: October 2014
• Est. completion date: March 2017

Study information

• Verified date: June 2016
• Source: SurgiQuest, Inc.
• Contact: cynthia Harris, BS
• Phone: 775-392-2970
• Email: cindy[@]clinregconsult.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subcutaneous Emphysema
• Wounds and Injuries

Intervention

Device:
• SurgiQuest AirSeal Insufflation System (AIS)
Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
• Conventional Insufflation System (CIS)
Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
SurgiQuest, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of insufflation device related subcutaneous emphysema (SCE) at 2 hours	Rate of insufflation device related subcutaneous emphysema(SCE)	2 hours post procedure	No
Primary	Rate of insufflation device related subcutaneous emphysema (SCE) at 4 hours	Rate of insufflation device related subcutaneous emphysema(SCE)	4 hours post procedure	No
Primary	Rate of insufflation device related subcutaneous emphysema (SCE) at 8 hours	Rate of insufflation device related subcutaneous emphysema(SCE)	8 hours post procedure	No
Primary	Rate of insufflation device related subcutaneous emphysema (SCE) at 12 hours	Rate of insufflation device related subcutaneous emphysema(SCE)	12 hours post procedure	No
Primary	Rate of insufflation device related subcutaneous emphysema (SCE) at 24 hours	Rate of insufflation device related subcutaneous emphysema(SCE)	24 hours post procedure	No
Secondary	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	2, hours post procedure	No
Secondary	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	4 hours post procedure	No
Secondary	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	8 hours post procedure	No
Secondary	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	12 hours post procedure	No
Secondary	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	24 hours post procedure	No