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

NCT07312006 | Not Yet Recruiting FDA Device

• 1 other identifier: DD 02250910
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

Post-Procedure Comparative Pain Study

Outcome Measures

Primary Outcomes (1)

• Pain Assessment on a 0 - 10 numerical rating scale (NRS)

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

  48 hours after surgery

Secondary Outcomes (1)

• 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)

Study Arms (2)

AirSeal® Insufflation System (AIS)

ACTIVE COMPARATOR

Use of AirSeal® Insufflation System (AIS) during robotic laparoscopic sleeve gastrectomy.

Device: AirSeal Insufflation system

DV5 Insufflator

ACTIVE COMPARATOR

Use of DV5 Insufflator during robotic laparoscopic sleeve gastrectomy.

Device: DV5 Insufflation system

Interventions

AirSeal Insufflation system DEVICE

AirSeal Insufflation system used during robotic sleeve gastrectomy

AirSeal® Insufflation System (AIS)

DV5 Insufflation system DEVICE

DV5 Insufflation system used during robotic laparoscopic sleeve gastrectomy.

DV5 Insufflator

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- • 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• SurgiQuest, Inc.: lead

Study Sites (1)

Baptist Health South Miami Hospital

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Anthony Gonzalez, MD FACS

  Baptist Health South Miami Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia L Harris, BS

CONTACT

8326776747; cindy@clinregconsult.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 28, 2025
• First Posted: December 31, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)