Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The "CAT5-GS" Study
NCT07312006 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2025-12-31
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.
Conditions
- Pain, Postoperative
Interventions
- DEVICE
-
AirSeal Insufflation system
AirSeal Insufflation system used during robotic sleeve gastrectomy
- DEVICE
-
DV5 Insufflation system
DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy.
Sponsors & Collaborators
-
SurgiQuest, Inc.
lead INDUSTRY
Principal Investigators
-
Anthony Gonzalez, MD FACS · Baptist Health South Miami Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-30
- Primary Completion
- 2026-10-30
- Completion
- 2027-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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