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ObesityNCT07310875

Gastric Ultrasound in Patients Who Have Undergone Bariatric Surgery

A study testing Gastric Point of Care Ultrasound in people with Obesity and Weight Loss, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Obesity, Weight Loss, Gastrectomy
What is being tested?
Gastric Point of Care Ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Dec 2025to 30 Dec 2026
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-85 years old
  • scheduled to undergo bariatric surgery
  • no prior abdominal surgery

Who cannot join

  • ASA physical status > 3
  • Urgent or emergent surgery
  • Patient refusal or inability to consent
  • Prior abdominal surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Diane C Armenta, MD, MS contact

845-260-0573

Diane.Armenta@mountsinai.org

United States1 site
  • Mount Sinai West and Morningside

    New York, New York, 10025

    Diane C Armenta, MD, MS, 845-260-0573, Diane.Armenta@mountsinai.org

    Malikah Latmore, MD, 917-364-3377, Malikah.Latmore@mountsinai.org

Other trials in United States

About this study

This is a nonrandomized prospective study. The purpose is to describe how to image the stomachs of patients after the patients have had bariatric surgery. Participants will have the stomachs imaged while undergoing general anesthesia for a bariatric procedure pre-operatively and post-operatively using point-of-care ultrasound (POCUS). The pre-operative imaging will be done post-intubation and the post-operative imaging will be done pre-extubation. There are minimal risks to gastric POCUS. Risks typically include discomfort to the patient, which will be avoided as the patient will be under general anesthesia at the time of imaging.

Read the detailed description

Aspiration of gastric contents in the perioperative period is a well-known complication with potentially disastrous consequences. Gastric POCUS is a tool clinicians can utilize to assess stomach fullness and risk stratify prior to induction of anesthesia. There is currently no literature describing how bariatric surgeries impact the location of the stomach and/or the ability of clinicians to obtain gastric POCUS images. Recent increased use of GLP-1 agonists, which delay gastric emptying, has renewed conversations surrounding using gastric POCUS to assess aspiration risk. Case reports have been published showing aspiration events in patients taking GLP-1 agonists despite an adequate fasting period. Additionally, recent studies have shown that these medications can help patients who have undergone bariatric surgery and then regained the weight, lose said weight. Given the possibility that patients may be post-bariatric surgery and currently taking GLP-1 agonists, POCUS is an important skill to utilize that can help anesthesiologists assess aspiration risk. This study will aim to fill a gap in the literature by describing how bariatric surgery can impact the location of the stomach and how to obtain sonographic images of the stomach in a post-bariatric surgery abdomen. The analysis will include description of how the images were obtained (ex: needing to rotate the probe further than expected, or stomach displacement, etc.) and comparison to the procedure used to obtain preoperative images. The measurements will be subjective to the PI who is certified in POCUS use.

Discussions will be held with surgeons who perform bariatric surgery, to determine which patients fit the qualifications to participate in the study. Patients are routinely seen by anesthesiologists for their anesthetic evaluation in the pre-operative holding area on the day of their procedure. After the patient have been evaluated, the patient will have time to discuss the study with the anesthesia team prior to transferring the patient to the OR. Consent will be obtained in the preoperative holding area. There are sequestered rooms in this area where patients can be brought for increased privacy during the consent process. The team will finalize participation and ask the participant to sign the study consent forms. All patient will be provided with copies of the IRB protocol and consent if the patient wish to have it. If agreeable to joining the study, the patient will undergo gastric POCUS after intubation. To perform the gastric POCUS, the patient will be in the supine position and the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient just below the xiphoid. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. The POCUS of the abdomen before abdominal surgery will be done before the surgical team has prepared a sterile field for their surgery. Therefore, there is no need to maintain sterile precautions when using the ultrasound on the abdomen. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS before extubation.

Being tested
Gastric Point of Care Ultrasound
Keywords
Point of Care Ultrasound, Sleeve gastrectomy
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastric Point of Care UltrasoundProcedure or surgery

    After the patient has undergone intubation, the patient will be positioned in the supine and then the right lateral decubitus position on the operating room table. A curvilinear ultrasound probe with gel will be placed on the patient below the xiphoid process. A picture is then obtained of the antrum of the stomach. The probe may need to be moved, tilted, or rotated to obtain the clearest image of the antrum of the stomach. After the images are obtained, the patient will be repositioned to supine for the procedure. Once the surgical procedure is complete, the patient will once again undergo gastric POCUS prior to extubation.

Study groups in NCT07310875
Study groupRoleWhat they receive
Gastric Point of Care Ultrasound (POCUS) groupExperimentalParticipates scheduled to undergo bariatric surgery and have had no prior abdominal surgery.
Receives: Procedure: Gastric Point of Care Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in distance from peritoneal wall

    Range: 3-5 cm. Higher score indicates greater displacement and less utility of gastric point-of-care ultrasound in these patients.

    Measured: end of the individual's procedure, at 2 hrs after procedure start on postoperative day 0

  2. Gastric antrum Cross-sectional area (CSA)

    Range: 1-10 centimeters squared. Gastric antrum Cross-sectional area (CSA) is a calculated product of Anteroposterior (AP) Diameter and Craniocaudal (CC) diameter. (CSA = AP x CC) Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.

    Measured: end of the individual's procedure, at 2 hrs after procedure start

Secondary outcomes (3)
  1. Anteroposterior (AP) Diameter

    Range: 0-10 centimeters. Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.

    Measured: end of the individual's procedure, at 2 hrs after procedure start

  2. Craniocaudal (CC) diameter

    Range: 0-10 centimeters. Higher score means that patient has a larger gastric volume and is at a higher aspiration risk.

    Measured: end of the individual's procedure, at 2 hrs after procedure start

  3. Postoperative aspiration events

    Number of Postoperative aspiration events

    Measured: until day of hospital discharge, average 1-3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07310875
Sponsor's protocol ID
STUDY-23-01595
Status last verified
Dec 2025
First submitted
16 Dec 2025
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • Pai SL, Bojaxhi E, Logvinov II, Porter SB, Feinglass NG, Robards CB, Torp KD. Ultrasound Assessment of Gastric Volume After Bariatric Surgery: A Case Report. A A Pract. 2019 Jan 1;12(1):1-4. doi: 10.1213/XAA.0000000000000824.

    PubMed 29985844
  • Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.

    PubMed 12768174
  • Gulak MA, Murphy P. Regurgitation under anesthesia in a fasted patient prescribed semaglutide for weight loss: a case report. Can J Anaesth. 2023 Aug;70(8):1397-1400. doi: 10.1007/s12630-023-02521-3. Epub 2023 Jun 6.

    PubMed 37280458

Questions about this trial

What is this clinical trial studying?

A study testing Gastric Point of Care Ultrasound in people with Obesity and Weight Loss, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 4 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 30 Dec 2025. 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 Diane C Armenta, MD, MS (845-260-0573, Diane.Armenta@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in distance from peritoneal wall (time frame: end of the individual's procedure, at 2 hrs after procedure start on postoperative day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07310875, which also lists 3 linked publications.

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 30 Dec 2025.

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