NCT02262884

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: SurgiQuest, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subcutaneous Emphysema

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2014-10-13
• Last updated: 2016-06-06

Locations

3 sites across 1 country: United States