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CAT5-GS Study: Comparing Insufflation Systems in Gastric Sleeve Surgery

This study, called CAT5-GS, is comparing two different devices used during robotic laparoscopic sleeve gastrectomy surgery: the AirSeal Insufflation system and the DV5 Insufflation system. These systems help surgeons see better during the procedure. The study aims to see if one system leads to less pain after surgery, specifically shoulder, neck, and chest pain. Researchers will measure your pain using a 0-10 scale 48 hours after your surgery. You may be able to join if you are between 22 and 65 years old, are having a non-emergency sleeve gastrectomy, and can understand and agree to participate. The study plans to enroll 74 participants, but its current status is unclear.

Study design
This is a single-center, prospective, randomized, controlled study comparing two different insufflation systems during surgery. It plans to enroll 74 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be assessed 48 hours after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07312006

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

Not Yet Recruiting
NAAges 22–65InterventionalTreatment
SurgiQuest, Inc.
~74 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:AirSeal Insufflation systemDV5 Insufflation system

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Assessment on a 0 - 10 numerical rating scale (NRS)
Measured over 48 hours after surgery

Conditions

Pain, Postoperative

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Obesity

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Anthony Gonzalez, MD FACS · PRINCIPAL_INVESTIGATOR · Baptist Health South Miami Hospital

Who to contact

Cynthia L Harris, BS
[email protected]
8326776747
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 visit
Chronic renal failure or on dialysis
Significant complicating medical history or immunocompromised
Subject is undergoing surgery for malignant disease
History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma
Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders
Any medical condition which precludes compliance with the study
Subject with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study or which would contra-indicate a surgical procedure
Previous or current history of being on regular analgesia / pain killers
Advanced refusal of blood transfusion, (if necessary)
If female subject pregnant, planning to become pregnant within 3 months (up to 92 days of procedure), or lactating

What this trial measures

  • Pain Assessment on a 0 - 10 numerical rating scale (NRS)48 hours after surgery

    Post-Operative shoulder, neck, chest pain, and abdominal pain