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Which gas blower hurts less after Weight-Loss surgery?

NCT ID NCT07313930

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two devices that blow gas into the belly during laparoscopic sleeve gastrectomy (a weight-loss surgery). The goal is to see if one device causes less pain after surgery than the other. About 74 adults aged 22 to 65 having planned sleeve gastrectomy will be randomly assigned to one device or the other, and their pain levels will be measured.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AirSeal® Insufflation System (device) and Lexicon AP 50/30 Insufflator (device)
What this could lead to
If one device works better, it could lead to less pain after weight-loss surgery and faster recovery.
What could go wrong
This is a small, early study with only 74 people at one center, so results may not apply to everyone. The devices are already approved, so no major breakthrough is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * . 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

obesity disorder Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bariatric and Specialty Surgery Center of Stamford

    Stamford, Connecticut, 06902, United States

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