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GALPT: Comparing Insufflation Devices in Gastrectomy

This study, called GALPT, is comparing two different devices used during laparoscopic sleeve gastrectomy (a type of weight-loss surgery) to inflate your abdomen: the AirSeal® Insufflation System (AIS) and the Lexicon AP 50/30 Insufflator. Researchers want to see if one device leads to less pain after surgery. You may be able to join if you are between 22 and 65 years old, need sleeve gastrectomy surgery, and can understand and agree to participate. The main goal is to measure your pain level 48 hours after surgery. The study is currently recruiting about 74 participants, but its overall status is unclear.

Study design
This is a randomized, controlled study comparing two devices during surgery. About 74 participants are planned to join.
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.

NCT07313930

Gastrectomy at Low Pressure Trial - (GALPT)

Not Yet Recruiting
NAAges 22–65InterventionalTreatment
SurgiQuest, Inc.
~74 participants
Updated 2026-01-02 on ClinicalTrials.gov
What's tested:AirSeal® Insufflation System (AIS)Lexicon AP 50/30 Insufflator

At a glance

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

Conditions

Pain, Postoperative

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Nikhilesh Sekhar, MD FACS FASMBS · PRINCIPAL_INVESTIGATOR · Bariatric and Specialty Surgery Center of Stamford

Who to contact

cynthia Harris, BS
[email protected]
18326776747
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

. Subject indicated for non-emergent sleeve gastrectomy surgery
. Subject (or appropriate legal representatives) can 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 graded as 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 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 immunocompromise
Subject 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

  • Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS).48 hours after surgery

    Post-Operative Pain (shoulder, neck, chest and abdominal) assessment