Insufflation Devices for Laparoscopic Sleeve Gastrectomy

(GALPT Trial)

Overseen By cynthia Harris, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SurgiQuest, Inc.

Must not be taking: Analgesics, Steroids, Chemotherapy, others

Disqualifiers: Hypertension, Diabetes, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two devices used during laparoscopic sleeve gastrectomy, a type of weight-loss surgery. The researchers will evaluate the CONMED AirSeal Insufflation System (AIS) and Lexicon AP 50/30 Insufflator devices to determine which performs better in this surgery. They seek participants planning to undergo this surgery who can agree to avoid any other body-altering procedures during the trial. As an unphased trial, it offers participants the chance to contribute to advancements in surgical technology and improve outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that these insufflation devices are safe for laparoscopic sleeve gastrectomy?

Research has shown that the AirSeal® Insufflation System is generally safe for keyhole surgeries. In a study of over 11,500 patients, this system produced positive outcomes, including shorter surgery times and less nausea. Some studies also suggest it may reduce post-surgery pain.

The Lexicon AP 50/30 Insufflator is a respected device, featuring smoke removal and steady gas flow. Although specific safety data from trials is not detailed, its use in surgeries indicates effective performance.

Both devices aim to make surgeries smoother and safer. Evidence so far suggests they are well-tolerated by patients, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of insufflation devices for laparoscopic sleeve gastrectomy because these devices could change the way gas is managed during surgery, potentially improving patient outcomes. The AirSeal® Insufflation System (AIS) is designed to maintain stable pressure in the abdomen and provide continuous smoke evacuation, which could lead to better visibility and fewer interruptions during surgery. On the other hand, the Lexicon AP 50/30 Insufflator aims to offer precise control over gas flow and pressure, which might reduce the risk of complications. By comparing these advanced devices, researchers hope to find out if they can make surgeries safer and more efficient compared to traditional insufflation methods.

What evidence suggests that these insufflation devices are effective for Laparoscopic Sleeve Gastrectomy?

This trial will compare the AirSeal Insufflation System with the Lexicon AP 50/30 Insufflator during laparoscopic sleeve gastrectomy. Research has shown that the AirSeal Insufflation System can make laparoscopic surgery faster and more comfortable for patients. Specifically, surgeries using AirSeal are about 12.6% shorter, with patients experiencing less nausea and a tendency towards less pain. Additionally, AirSeal improves breathing during surgery by better controlling air pressure.

The Lexicon AP 50/30 Insufflator, another treatment option in this trial, uses warm, moist air during surgery. This method aims to reduce post-surgery pain by keeping tissues moist, which can also aid in healing. Both systems are designed to improve the surgical experience, but they operate differently. ^{1 2 3 4 6}

Who Is on the Research Team?

Nikhilesh Sekhar, MD FACS FASMBS

Principal Investigator

Bariatric and Specialty Surgery Center of Stamford

Are You a Good Fit for This Trial?

This trial is for adults aged 22-65 who are in good health (ASA Class I, II, or III), need non-emergency sleeve gastrectomy surgery, and can consent to the study. They must not plan any weight-affecting procedures during the trial and should have no severe mental health issues that could affect participation.

Inclusion Criteria

Subject (or appropriate legal representatives) can provide written informed consent to participate in the study

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

I am considered fit for surgery based on my overall health.

Exclusion Criteria

Any medical condition which precludes compliance with the study

Subject falls into American Society of Anesthesiologists (ASA) Class ≥ IV

History of chronic alcohol or drug abuse within 2 years of the screening visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo Laparoscopic Sleeve Gastrectomy using either the CONMED AirSeal® or Lexicon Insufflators

1 day

1 visit (in-person)

Immediate Post-Operative

Participants are monitored for procedure time, recovery room time, and length of stay

2 days

Continuous monitoring

Follow-up

Participants are monitored for post-operative pain and recovery progress

2 days

What Are the Treatments Tested in This Trial?

Interventions

• AirSeal® Insufflation System (AIS)
• Lexicon AP 50/30 Insufflator

Trial Overview

The GALPT compares two insufflation devices used in laparoscopic sleeve gastrectomy: the AirSeal® Insufflation System (AIS) versus the Lexicon AP 50/30 Insufflator. The goal is to see which device leads to less postoperative pain.

How Is the Trial Designed?

Group I: Lexicon Insufflator Active Control 1 Intervention

Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.

Group II: AirSeal® Insufflation System (AIS) Active Control 1 Intervention

Use of CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy.

Who Is Running the Clinical Trial?

SurgiQuest, Inc.

Lead Sponsor

Trials

6

Recruited

670+

Citations

1.

conmed.com

conmed.com/en/products/airseal-and-insufflation/airseal-data

AirSeal Clinical Study Appendix

Procedures in AirSeal group were 12.6% shorter in duration; Patients in AirSeal group had fewer episodes of nausea (2% vs 10%); Trend toward less pain in the ...

2.

sages.org

sages.org/meetings/annual-meeting/abstracts-archive/retrospective-study-of-the-airsealtm-system-for-laparoscopic-bariatric-surgery/

Retrospective Study Of The AirSeal(tm) System For ...

Conclusion: The Airseal(tm) system in laparoscopic bariatric surgery is safe and leads to decreased operative times. This can potentially decrease the overall ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39042265/

a systematic review and meta-analysis

This meta-analysis aimed to compare perioperative outcome measures between the AirSeal system and conventional insufflation system in robot-assisted ...

4.

liebertpub.com

liebertpub.com/doi/10.1089/lap.2022.0153?doi=10.1089/lap.2022.0153

The Role of AirSeal in Robotic Urologic Surgery

AirSeal resulted in improved respiratory parameters, specifically lower inspiratory plateau pressure, lower minute volume, lower CO2 elimination rate, low end- ...

5.

withpower.com

withpower.com/trial/phase-pain-postoperative-2026-18369

AirSeal vs DV5 for Postoperative Pain ("CAT5-GS" Trial)

A study to compare two different insufflation devices during robotic laparoscopic sleeve gastrectomy surgery, AirSeal to DV5 insufflation, in ...

6.

conmed.com

conmed.com/en/products/airseal-and-insufflation/airseal-ifs-intelligent-flow-system

AirSeal® Insufflation

A total of 11,520 patients were enrolled across 38 peer-reviewed publications that demonstrate positive patient outcomes of AirSeal® insufflation, spanning 7 ...