Which air pump causes less pain after Weight-Loss surgery?
NCT ID NCT07312006
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two devices used during robotic gastric sleeve surgery to see which causes less shoulder, neck, and chest pain afterward. About 74 adults having non-emergency sleeve gastrectomy will be randomly assigned to receive either the AirSeal or DV5 insufflation system. Researchers will measure pain levels and recovery times to find out if one device is better for patient comfort.
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 and DV5 Insufflation system (medical devices used during surgery)
- What this could lead to
- If one device works better, it could mean less pain after gastric sleeve surgery, helping patients recover more comfortably.
- What could go wrong
- This is a small, early-stage study (74 people) comparing two devices, so results may not apply to everyone. Pain is subjective and can vary widely.
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
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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
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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22 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 * Subjects (or appropriate legal representatives) able to 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 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 who 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 immunocompromised * Subject is 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Baptist Health South Miami Hospital
Miami, Florida, 33176, United States
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