Pain, PostoperativeGALPTNCT07313930
Gastrectomy at Low Pressure Trial - (GALPT)
A study testing AirSeal® Insufflation System (AIS) and Lexicon AP 50/30 Insufflator in people with Pain, Postoperative, run by SurgiQuest, Inc. at 1 site in United States.
Trial summary
The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- AirSeal® Insufflation System (AIS) and Lexicon AP 50/30 Insufflator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Bariatric and Specialty Surgery Center of Stamford
Stamford, Connecticut, 06902
Carolina Castellano, MSN RN AGPCNP-BC, 203-610-4075, ccastellano@nybg.com
Nikhilesh R Sekhar, MD FACS FASMBS
About this study
Official title: A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes Using the CONMED AirSeal® and Lexicon Insufflators During Laparoscopic Sleeve Gastrectomy.
The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.
Read the detailed description
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
- Conditions
- Pain, Postoperative
- Being tested
- AirSeal® Insufflation System (AIS), Lexicon AP 50/30 Insufflator
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSeal® Insufflation System (AIS)Device
insufflation device used during laparoscopic sleeve gastrectomy,
Lexicon AP 50/30 InsufflatorDevice
insufflation device used during laparoscopic sleeve gastrectomy,
| Study group | Role | What they receive |
|---|---|---|
| AirSeal® Insufflation System (AIS) | Active comparator | Use of CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy. Receives: Device: AirSeal® Insufflation System (AIS) |
| Lexicon Insufflator | Active comparator | Use of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy. Receives: Device: Lexicon AP 50/30 Insufflator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS).
Post-Operative Pain (shoulder, neck, chest and abdominal) assessment
Measured: 48 hours after surgery
Secondary outcomes (1)
Time
Procedure time, recovery room time, length of stay time
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SurgiQuest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikhilesh Sekhar, MD FACS FASMBS, Principal investigator, Bariatric and Specialty Surgery Center of Stamford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313930
- Sponsor's protocol ID
- DD1250901
- Acronym
- GALPT
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We are looking at the aggregate statistics
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes Using the CONMED AirSeal® and Lexicon Insufflators During Laparoscopic Sleeve Gastrectomy.
- ClinicalTrials.gov ID
- NCT07313930
- Acronym / sponsor ID
- GALPT / DD1250901
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- SurgiQuest, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.
Detailed description
A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Single-Center, Prospective, Randomized, Controlled Study Comparing Intraoperative and Perioperative Outcomes using the CONMED AirSeal® and Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy.
| Arm | Type | Receives |
|---|---|---|
| AirSeal® Insufflation System (AIS) | Active comparator | Device: AirSeal® Insufflation System (AIS)Use of CONMED AirSeal® during Laparoscopic Sleeve Gastrectomy. |
| Lexicon Insufflator | Active comparator | Device: Lexicon AP 50/30 InsufflatorUse of Lexicon Insufflators during Laparoscopic Sleeve Gastrectomy. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- . 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirSeal® Insufflation System (AIS)insufflation device used during laparoscopic sleeve gastrectomy, | Device | AirSeal® Insufflation System (AIS) |
| Lexicon AP 50/30 Insufflatorinsufflation device used during laparoscopic sleeve gastrectomy, | Device | Lexicon Insufflator |
Primary outcome
Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS).
Time frame: 48 hours after surgery
Post-Operative Pain (shoulder, neck, chest and abdominal) assessment
1 secondary outcome
Time
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No. We are looking at the aggregate statistics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikhilesh Sekhar, MD FACS FASMBS principal investigator
Bariatric and Specialty Surgery Center of Stamford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirSeal® Insufflation System (AIS) and Lexicon AP 50/30 Insufflator in people with Pain, Postoperative, run by SurgiQuest, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact cynthia Harris, BS (18326776747, cindy@clinregconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Pain assessment on a 0-10 numerical rating scale(NRS). (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.