Gastrectomy at Low Pressure Trial - (GALPT)

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
SurgiQuest, Inc.
Study ID
NCT07313930
Status
Not Yet Recruiting

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Conditions

  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AirSeal® Insufflation System (AIS) — DEVICE
    insufflation device used during laparoscopic sleeve gastrectomy,
  • Lexicon AP 50/30 Insufflator — DEVICE
    insufflation device used during laparoscopic sleeve gastrectomy,

Study Details

The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.

Key Dates

Start date
Jan 10, 2026
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AirSeal® Insufflation System (AIS)
    Use of CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy.
  • Active Comparator: Lexicon Insufflator
    Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.

Primary Outcome Measure

Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS). [ Time Frame: 48 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bariatric and Specialty Surgery Center of StamfordStamfordConnecticut06902
Carolina Castellano, MSN RN AGPCNP-BC
[email protected]
203-610-4075
Nikhilesh R Sekhar, MD FACS FASMBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stamford, CT

By research site
Bariatric and Specialty Surgery Center of Stamford· Stamford, CT

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