Recruiting

FUS

Sponsor:

Evan (Huiliang) Wang

Code:

NCT07851727

Conditions

Gastroparesis

Delayed Gastric Emptying

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Gastric Focused Ultrasound Stimulation

Study Details

Brief 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. 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.

Conditions

Gastroparesis

Delayed Gastric Emptying

Study ID

NCT07851727

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Sep 11, 2027

Anticipated

Primary completion date

Jun 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Gastric Focused Ultrasound Stimulation

Participants 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.

sham comparator: Sham Gastric Focused Ultrasound Stimulation

Participants 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.

Interventions

Gastric Focused Ultrasound Stimulation

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.

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. ]
  • Change in Gastric Dominant Frequency Measured by Electrogastrography [ Time Frame: 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. ]
  • Change in Gastric EGG Signal Amplitude [ Time Frame: 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. ]
  • Change in Percentage of Time in Normal Gastric Rhythm [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Mengmeng Yao, Ph.D.

5732343390mmyao1102@gmail.com

Locations

Biomedical Engineering Building

Recruiting

Austin, Texas, United States, 78712

Contacts

Mengmeng Yao

5732343390mmyao1102@gmail.com

More Information

Sponsor

Evan (Huiliang) Wang

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Electrogastrography
  • Ultrasound
  • Sham-Controlled Study
  • Non-invasive Stimulation
  • Gastric
  • Gastric stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Evan (Huiliang) Wang on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.