Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The "CAT5-GS" Study
SurgiQuest, Inc.
Summary
A study to compare two different insufflation devices during robotic laparoscopic sleeve gastrectomy surgery, AirSeal to DV5 insufflation, in Gastric Sleeve Procedures. Shoulder, neck and chest pain will be assessed.
Description
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and DV5 Insufflators during Robotic Laparoscopic Sleeve Gastrectomy.
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- • Subject indicated for non-emergent sleeve gastrectomy surgery * Subjects (or appropriate legal representatives) able to provide written informed consent to participate in the study * Male or Female aged 22 years to 65 years * Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations and office visits * Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of ex…
Interventions
- DeviceAirSeal Insufflation system
AirSeal Insufflation system used during robotic sleeve gastrectomy
- DeviceDV5 Insufflation system
DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy.
Location
- Baptist Health South Miami HospitalMiami, Florida