Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The "CAT5-GS" Study

Part of paid clinical trials in Miami, Florida.

Sponsor
SurgiQuest, Inc.
Study ID
NCT07312006
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 — DEVICE
    AirSeal Insufflation system used during robotic sleeve gastrectomy
  • DV5 Insufflation system — DEVICE
    DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy.

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Dec 2025
Primary completion
Oct 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 AirSeal® Insufflation System (AIS) during robotic laparoscopic sleeve gastrectomy.
  • Active Comparator: DV5 Insufflator
    Use of DV5 Insufflator during robotic laparoscopic sleeve gastrectomy.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baptist Health South Miami HospitalMiamiFlorida33176
Michelle Gallas, PhD
[email protected]
305-495-8924
Anthony Gonzalez, MD FACS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Baptist Health South Miami Hospital· Miami, FL

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