Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The "CAT5-GS" Study (NCT07312006) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The "CAT5-GS" Study
United States74 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 excess skin for the duration of the trial.
* Are American Society of Anesthesiologists (ASA) Class I, II, or III);
Exclusion Criteria:
* Subject participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor)
* Subject requiring any surgical procedure in addition to Sleeve Gastrectomy
* Previous malabsorptive or restrictive procedures performed for the treatment of obesity
* Inability to provide informed consent
* Unable or unwilling to attend follow-up visits and examinations
* Uncontrolled hypertension (Systolic: ≥180 mmHg or Diastolic: ≥120 mmHg) and/or diabetes mellitus (Fasting blood sugar level: \>200 mg/dL)
* Subject who falls into American Society of Anesthesiologists (ASA) Class ≥ IV
* History of chronic alcohol or drug abuse within 2 years of the screening…
What they're measuring
1
Pain Assessment on a 0 - 10 numerical rating scale (NRS)