SurgiQuest AirSeal in Robotic Partial Nephrectomy - (TARPAN Study)

A Physician Preference Study of the Use of SurgiQuest AirSeal vs. Conventional Insufflation Systems for the Management of Pneumoperitoneum in Robotic Partial Nephrectomy .

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02262884

Acronym

TARPAN

Enrollment

189

Registered

2014-10-13

Start date

2014-10-31

Completion date

2017-03-31

Last updated

2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subcutaneous Emphysema

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.

Interventions

DEVICESurgiQuest 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.

DEVICEConventional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame	Description
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 4 hours	4 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 12 hours	12 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)

Secondary

Measure	Time frame	Description
Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) required pain medication, measured with Visual Analogue Scale (VAS)	2, hours post procedure	Rate of Pneumothorax, Pneumomediastinum, Post op pain (general/shoulder) measured with Visual Analogue Scale (VAS), required pain medication

Countries

United States

Contacts

Primary Contactcynthia Harris, BS

cindy@clinregconsult.com775-392-2970

Backup ContactMichael Daniel, BS,MS,MBA

MADaniel@clinregconsult.com775-392-2970

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026