Gastrectomy at Low Pressure Trial - (GALPT)

NCT07313930 | Not Yet Recruiting FDA Device

• 1 other identifier: DD1250901
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

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

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

  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 CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy.

Device: AirSeal® Insufflation System (AIS)

Lexicon Insufflator

ACTIVE COMPARATOR

Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.

Device: Lexicon AP 50/30 Insufflator

Interventions

AirSeal® Insufflation System (AIS) DEVICE

insufflation device used during laparoscopic sleeve gastrectomy,

AirSeal® Insufflation System (AIS)

Lexicon AP 50/30 Insufflator DEVICE

insufflation device used during laparoscopic sleeve gastrectomy,

Lexicon 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
• 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.

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 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

Sponsors & Collaborators

• SurgiQuest, Inc.: lead

Study Sites (1)

Bariatric and Specialty Surgery Center of Stamford

Stamford, Connecticut, 06902, 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

• Nikhilesh Sekhar, MD FACS FASMBS

  Bariatric and Specialty Surgery Center of Stamford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cynthia Harris, BS

CONTACT

18326776747; 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 Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 2, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)