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GastroparesisNCT07851727

Gastric Focused Ultrasound Stimulation

A study testing Gastric Focused Ultrasound Stimulation in people with Gastroparesis and Delayed Gastric Emptying, run by Evan (Huiliang) Wang at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This randomized, sham-controlled crossover pilot study will evaluate whether noninvasive gastric focused ultrasound stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adults with gastroparesis or delayed gastric emptying. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastroparesis, Delayed Gastric Emptying
What is being tested?
Gastric Focused Ultrasound Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
11 Sep 2026to 11 Sep 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 70 years.
  • Delayed gastric emptying or gastroparesis diagnosed by a clinician and confirmed by gastric emptying scintigraphy or a gastric emptying breath test.
  • Ability to understand the study procedures, provide informed consent, and complete two study visits.
  • Ability to consume the two bottles of Ensure or Glucerna nutritional drink used in the study.

Who cannot join

  • Pregnancy.
  • Epilepsy.
  • Cardiac pacemaker or another implanted electronic medical device.
  • Peritoneal dialysis.
  • Daily use of narcotic or opioid medications.
  • Abdominal wall ulcers, open wounds, active infection, or significant skin irritation in the area where the electrogastrography electrodes or focused ultrasound transducer will be placed.
Show all 10Show fewer
  • Known allergy or contraindication to the available Ensure or Glucerna nutritional drinks.
  • Any other medical or safety condition that, in the judgment of the study team, would make participation unsafe.
  • Medication Restrictions:
  • Participants using medications that may significantly affect gastric motility or gastric emptying may be rescheduled if those medications were used within the study-defined restriction period. Relevant medications include opioid analgesics, prokinetic agents, anticholinergic or antispasmodic agents, GLP-1 receptor agonists or related medications, and anti-nausea or antiemetic medications that may affect gastrointestinal function. Participants should not discontinue any medically necessary medication without first consulting their treating physician.

Trial locations and contacts

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

Mengmeng Yao, Ph.D. contact

5732343390

mmyao1102@gmail.com

United States1 site, 1 recruiting
  • Biomedical Engineering Building

    Austin, Texas, 78712

    Mengmeng Yao, 5732343390, mmyao1102@gmail.com

    Recruiting

Other trials in United States

About this study

Official title: Gastric Focused Ultrasound Stimulation for Gastroparesis Patients

This randomized, sham-controlled crossover pilot study will evaluate whether noninvasive gastric focused ultrasound stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adults with gastroparesis or delayed gastric emptying. Participants will complete one active FUS visit and one sham-stimulation visit in randomized order, separated by at least 48 hours. At each visit, electrogastrography will be recorded before and after a standardized liquid nutritional drink, during active or sham stimulation, and during recovery. Gastrointestinal symptoms will be assessed at prespecified time points using the Total Symptom Score questionnaire.

Read the detailed description

This exploratory pilot study will investigate whether noninvasive gastric focused ultrasound (FUS) stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adult patients with gastroparesis or clinically significant symptoms of delayed gastric emptying.

A total of 12 participants ages 18 to 70 years will complete two study visits in a randomized crossover design. During one visit, participants will receive active gastric focused ultrasound stimulation; during the other visit, they will receive sham stimulation. The order of active and sham stimulation will be randomized. The two visits will be separated by at least 48 hours to reduce potential carryover effects. When possible, visits will be scheduled at a similar time of day.

Participants will fast for at least 6 to 8 hours before each visit, except for water and medications permitted by their treating physician. At each visit, nine electrogastrography (EGG) electrodes will be placed on cleaned skin over the upper abdomen and stomach region. Participants will complete approximately 10 minutes of fasting baseline EGG recording, consume up to two bottles of Ensure or Glucerna nutritional drink within approximately 15 minutes as tolerated, and complete approximately 10 minutes of post-meal EGG monitoring.

Participants will then receive active FUS or sham stimulation according to their randomized visit assignment. Active stimulation will be delivered noninvasively through the abdominal skin over the stomach region using an ultrasound transducer and coupling gel. Active stimulation will use a center frequency of 650 kHz and pulse repetition frequency of 1 kHz. Each pulse will consist of 200 microseconds on and 800 microseconds off, corresponding to a 20% pulse-level duty cycle. Pulsed ultrasound will be delivered in repeated blocks of 500 milliseconds on and 500 milliseconds off throughout a total FUS session of 600 seconds. During the sham condition, transducer placement, coupling gel, device setup, and study procedures will be the same, but no active ultrasound energy will be delivered.

EGG signals will be recorded continuously during stimulation or sham and during approximately 10 minutes of post-stimulation recovery monitoring. Participants will report discomfort, warmth, tingling, nausea, pain, dizziness, or other symptoms. Study procedures may be paused or stopped at any time at the participant's request or if the study team identifies a safety concern.

Gastrointestinal symptom severity will be assessed using the Total Symptom Score questionnaire. The Total Symptom Score sums ratings of nausea, vomiting, early satiety, bloating, postprandial fullness, and abdominal pain. Each symptom is rated from 0 to 4, with a total score ranging from 0 to 24; higher scores indicate worse symptom severity. Symptom ratings will be collected at the past-two-week baseline assessment, immediately before stimulation, after meal consumption, immediately after FUS or sham stimulation, and 30 minutes after stimulation completion.

The study will evaluate EGG signal characteristics, including gastric slow-wave rhythm, dominant frequency, amplitude or power, and percentage of time in normal gastric rhythm, and will compare within-participant changes between active FUS and sham conditions. The study is intended to assess feasibility and preliminary physiological effects and is not designed to establish clinical efficacy.

Being tested
Gastric Focused Ultrasound Stimulation
Keywords
Electrogastrography, Ultrasound, Sham-Controlled Study, Non-invasive Stimulation, Gastric, Gastric stimulation
Medical subject headings
Gastroparesis

What participants receive

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

  • Gastric Focused Ultrasound StimulationDevice

    Noninvasive focused ultrasound stimulation will be delivered through the abdominal skin over the stomach region using an ultrasound transducer and coupling gel. Active stimulation will use a center frequency of 650 kHz and a pulse repetition frequency of 1 kHz. Each pulse will consist of 200 microseconds on and 800 microseconds off, corresponding to a 20% pulse-level duty cycle. Pulsed ultrasound will be delivered in repeated blocks of 500 milliseconds on and 500 milliseconds off during a total FUS session of 600 seconds.

Study groups in NCT07851727
Study groupRoleWhat they receive
Active Gastric Focused Ultrasound StimulationExperimentalParticipants will receive noninvasive gastric focused ultrasound stimulation during one randomized study visit. Participants will undergo fasting baseline EGG recording, consume up to two bottles of a standardized Ensure or Glucerna nutritional drink as tolerated, complete post-meal EGG monitoring, receive active FUS, and complete recovery EGG monitoring and symptom assessments.
Receives: Device: Gastric Focused Ultrasound Stimulation
Sham Gastric Focused Ultrasound StimulationSham comparatorParticipants will undergo the same procedures as during the active FUS visit, including fasting baseline EGG recording, standardized Ensure or Glucerna nutritional drink consumption, transducer placement, ultrasound coupling gel application, device setup, post-meal and recovery EGG monitoring, and symptom assessments. No active ultrasound energy will be delivered during the sham condition.
Receives: Device: Gastric Focused Ultrasound Stimulation

What is being measured

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

  1. Change in Gastrointestinal Symptom Severity Measured by Total Symptom Score

    The Total Symptom Score is the sum of participant-reported severity ratings for nausea, vomiting, early satiety, bloating, postprandial fullness, and abdominal pain. Each symptom is rated from 0 (absent) to 4 (extremely severe), yielding a total score ranging from 0 to 24; higher scores indicate greater symptom severity. Within-participant change in Total Symptom Score from immediately before stimulation to 30 minutes after completion of active FUS or sham stimulation will be compared between conditions.

    Measured: Immediately before stimulation and 30 minutes after completion of active FUS or sham stimulation at each study visit.

  2. Change in Gastric Dominant Frequency Measured by Electrogastrography

    Gastric dominant frequency will be derived from electrogastrography (EGG) recordings and reported in cycles per minute (cpm). Within-participant values during active FUS and sham stimulation will be compared.

    Measured: At each study visit: 10-min fasting baseline; 10-min post-meal recording before active FUS or sham; 10-min recording during active FUS or sham; and 10-min recovery recording immediately after stimulation.

  3. Change in Gastric EGG Signal Amplitude

    Gastric EGG signal amplitude will be derived from EGG recordings and reported in microvolts (µV). Within-participant values during active FUS and sham stimulation will be compared.

    Measured: At each study visit: 10-min fasting baseline; 10-min post-meal recording before active FUS or sham; 10-min recording during active FUS or sham; and 10-min recovery recording immediately after stimulation.

  4. Change in Percentage of Time in Normal Gastric Rhythm

    The percentage of analyzable EGG recording time with gastric dominant frequency within the normogastric range of 2 to 4 cycles per minute will be calculated and reported as a percentage. Within-participant values during active FUS and sham stimulation will be compared.

    Measured: At each study visit: 10-min fasting baseline; 10-min post-meal recording before active FUS or sham; 10-min recording during active FUS or sham; and 10-min recovery recording immediately after stimulation.

Timeline

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

  1. First posted1 Oct 2026
  2. Study start11 Sep 2026
  3. Primary completion11 Jun 2027 (estimated)
  4. Study completion11 Sep 2027 (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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a randomized, sham-controlled, within-subject crossover study. Each participant will complete two study visits in randomized order: one visit with active noninvasive gastric focused ultrasound stimulation and one visit with sham stimulation. Study visits will be separated by a washout period of at least 48 hours to reduce potential carryover effects. At each visit, participants will undergo the same fasting preparation, standardized liquid nutritional drink challenge, electrogastrography recording, symptom assessments, and safety monitoring. Each participant will serve as their own control for comparisons of active FUS and sham stimulation.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07851727
Sponsor's protocol ID
STUDY00009558
Status last verified
Nov 2026
First submitted
18 Sep 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.

    PubMed 23147521
  • Cheng LK. Slow wave conduction patterns in the stomach: from Waller's foundations to current challenges. Acta Physiol (Oxf). 2015 Feb;213(2):384-93. doi: 10.1111/apha.12406. Epub 2014 Nov 15.

    PubMed 25313679
  • O'Grady G, Gharibans AA, Du P, Huizinga JD. The gastric conduction system in health and disease: a translational review. Am J Physiol Gastrointest Liver Physiol. 2021 Nov 1;321(5):G527-G542. doi: 10.1152/ajpgi.00065.2021. Epub 2021 Sep 22.

    PubMed 34549598
  • Javid A, Ilham S, Kiani M. A Review of Ultrasound Neuromodulation Technologies. IEEE Trans Biomed Circuits Syst. 2023 Oct;17(5):1084-1096. doi: 10.1109/TBCAS.2023.3299750. Epub 2023 Nov 21.

    PubMed 37506009
  • Bashashati M, Andrews CN, Chen JDZ, McCallum RW, Koch KL. Gastric electrophysiology. Expert Rev Gastroenterol Hepatol. 2026 May;20(5):459-473. doi: 10.1080/17474124.2026.2663975. Epub 2026 Apr 28.

    PubMed 42018791
  • Song G, Sun Y, Bashashati M, Quezada A, Sigaroodi S, Sarosiek I, Chen JDZ, McCallum RW. Efficacy of needleless transcutaneous electroacupuncture in synchronization with breathing for symptomatic idiopathic gastroparesis: A blinded and controlled acute treatment trial. Neurogastroenterol Motil. 2018 Sep;30(9):e13361. doi: 10.1111/nmo.13361. Epub 2018 May 10.

    PubMed 29745434

Questions about this trial

What is this clinical trial studying?

A study testing Gastric Focused Ultrasound Stimulation in people with Gastroparesis and Delayed Gastric Emptying, run by Evan (Huiliang) Wang 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 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. Some participants in this study may receive a placebo. 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 Mengmeng Yao, Ph.D. (5732343390, mmyao1102@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gastrointestinal Symptom Severity Measured by Total Symptom Score (time frame: Immediately before stimulation and 30 minutes after completion of active FUS or sham stimulation at each study visit.). The study lists 4 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 NCT07851727, which also lists 6 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 4 Nov 2026.

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