Gastrectomy at Low Pressure Trial - (GALPT)
NCT07313930 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2026-01-02
Summary
The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.
Conditions
- Pain, Postoperative
Interventions
- DEVICE
-
AirSeal® Insufflation System (AIS)
insufflation device used during laparoscopic sleeve gastrectomy,
- DEVICE
-
Lexicon AP 50/30 Insufflator
insufflation device used during laparoscopic sleeve gastrectomy,
Sponsors & Collaborators
-
SurgiQuest, Inc.
lead INDUSTRY
Principal Investigators
-
Nikhilesh Sekhar, MD FACS FASMBS · Bariatric and Specialty Surgery Center of Stamford
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
- 2026-01-10
- Primary Completion
- 2026-09-30
- Completion
- 2027-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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