Sponsor:
SurgiQuest, Inc.
Code:
NCT02262884
Conditions
Subcutaneous Emphysema
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Interventions
SurgiQuest AirSeal Insufflation System (AIS)
Conventional Insufflation System (CIS)
Brief summary:
Conditions
Subcutaneous Emphysema
Study ID
NCT02262884
Start date
Oct, 2014
Status verified date
Jun, 2016
Completion date
Mar, 2017
Anticipated
Primary completion date
Dec, 2016
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Enrollment
189 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
active comparator: AIS @ 12mmHg pressure
active comparator: AIS @ 15mmHg pressure
active comparator: CIS @ 15mmHg pressure
Interventions
SurgiQuest AirSeal Insufflation System (AIS)
Conventional Insufflation System (CIS)
Primary outcome measure
Central contacts
Locations
Washington University School of Medicine
Recruiting
Saint Louis, Missouri, United States, 63110
Contacts
Principal Investigator:
Robert Figenshau, MD
Swedish Medical Center
Recruiting
Seattle, Washington, United States, 98122
Contacts
Sponsor
SurgiQuest, Inc.
Last update posted
Jun 6, 2016
Last verified
Jun, 2016
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SurgiQuest, Inc. on 2016-06-06.