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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: AirSeal Insufflation system; Device: DV5 Insufflation system

Detailed Description

A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and DV5 Insufflators during Robotic Laparoscopic Sleeve Gastrectomy.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia L Harris, BS; Phone Number: 8326776747; Email: cindy@clinregconsult.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Health South Miami Hospital
      • Contact: Michelle Gallas, PhD; Phone Number: 305-495-8924; Email: MichelleGal@baptisthealth.net
      • Principal Investigator: Anthony Gonzalez, MD FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AirSeal® Insufflation System (AIS); Use of AirSeal® Insufflation System (AIS) during robotic laparoscopic sleeve gastrectomy.	Device: AirSeal Insufflation system; AirSeal Insufflation system used during robotic sleeve gastrectomy
Active Comparator: DV5 Insufflator; Use of DV5 Insufflator during robotic laparoscopic sleeve gastrectomy.	Device: DV5 Insufflation system; DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Assessment on a 0 - 10 numerical rating scale (NRS)	Post-Operative shoulder, neck, chest pain, and abdominal pain	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time	Procedure time, recovery room time, stay time	1) Evening Surgery Day- (at 8 PM) 2) Morning- (Day 1 at 8:00 AM) 3) Evening- (Day 1 at 8 PM) 4) Morning -(Day 2 at 8 AM.) 5) Evening- (Day 2 at 8 PM)

Collaborators and Investigators

• Sponsor: SurgiQuest, Inc.
• Investigators: Principal Investigator: Anthony Gonzalez, MD FACS, Baptist Health South Miami Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Post-Procedure Comparative Pain Study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: DD 02250910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are just looking at the aggregate statistics.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes