12 Participants NeededMy employer runs this trial

Focused Ultrasound Stimulation for Gastroparesis

MY
Overseen ByMengmeng Yao, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new noninvasive treatment using focused ultrasound to help people with gastroparesis, a condition where the stomach takes too long to empty its contents. Researchers aim to determine if Gastric Focused Ultrasound Stimulation can alter stomach activity and improve symptoms after eating. Participants will attend two visits: one with the actual treatment and one with a sham version, to compare results. Suitable candidates have gastroparesis confirmed by tests and can drink two bottles of the nutritional drinks used in the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for gastroparesis.

What prior data suggests that gastric focused ultrasound stimulation is safe for gastroparesis?

Research has shown that gastric electrical stimulation (GES), a technology similar to gastric focused ultrasound stimulation, is generally safe for treating gastroparesis. Studies indicate that GES can reduce symptoms without causing major side effects. In one study, patients who received GES experienced no serious complications after the procedure. Another study confirmed that GES is safe and effective for long-term use in patients with severe gastroparesis.

Although focused ultrasound stimulation differs from GES, both aim to improve stomach function without surgery. Gastric focused ultrasound stimulation is currently being tested in an early-stage study, remaining in the initial research phase. However, the absence of serious side effects in similar treatments offers some reassurance about its potential safety in humans.12345

Why are researchers excited about this trial?

Researchers are excited about Gastric Focused Ultrasound Stimulation for gastroparesis because it offers a non-invasive alternative to current treatments. Unlike standard options like dietary changes, medications to stimulate stomach muscles, or even surgical interventions, this technique uses focused ultrasound energy to stimulate the stomach externally. The potential for reduced side effects and quicker recovery times makes this approach particularly promising. Additionally, it targets the stomach directly without the need for invasive procedures, which could make it a more appealing option for patients seeking less disruptive treatments.

What evidence suggests that gastric focused ultrasound stimulation is effective for gastroparesis?

Research has shown that focused ultrasound on the stomach is being studied as a treatment for gastroparesis, a condition where the stomach struggles to empty food. In this trial, participants will receive either active gastric focused ultrasound stimulation or a sham procedure. Although data on using ultrasound for this purpose remains limited, similar treatments like gastric electrical stimulation (GES) have shown promising results. Specifically, studies have found that GES can reduce vomiting by up to 62% and improve symptoms like nausea and stomach pain. The researchers aim to determine if focused ultrasound might work similarly by targeting the stomach to help manage symptoms and improve gastric emptying. This noninvasive method is still in the early stages but could potentially offer relief for people with gastroparesis.678910

Who Is on the Research Team?

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Huiliang Wang, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for adults who have gastroparesis or delayed stomach emptying. Participants must be able to attend two study visits and follow instructions. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Ability to consume the two bottles of Ensure or Glucerna nutritional drink used in the study
I am between 18 and 70 years old.
I can understand the study, give consent, and attend two study visits.
See 1 more

Exclusion Criteria

Pregnancy
Cardiac pacemaker or another implanted electronic medical device
I have epilepsy.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two study visits in a randomized crossover design, receiving either active gastric focused ultrasound stimulation or sham stimulation.

1 week
2 visits (in-person)

Follow-up

Participants are monitored for changes in gastric electrical activity and gastrointestinal symptoms after each treatment session.

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Gastric Focused Ultrasound Stimulation

Trial Overview

The study tests a noninvasive treatment called gastric focused ultrasound stimulation (FUS) to see if it changes stomach activity or symptoms after eating, compared to a sham (inactive) procedure. Each participant receives both treatments in random order.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Gastric Focused Ultrasound StimulationExperimental Treatment1 Intervention
Group II: Sham Gastric Focused Ultrasound StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Evan (Huiliang) Wang

Lead Sponsor

Citations

NCT07851727 | Gastric Focused Ultrasound Stimulation

The study is intended to assess feasibility and preliminary physiological effects and is not designed to establish clinical efficacy.

Efficacy of Gastric Electrical Stimulation for Gastroparesis - PMC

Vomiting was decreased by 62% after GES implant in the European centers and by 45% in the US centers. In the European. TSS was decreased by 48%, Patients ...

Gastroparesis

This study is using pulsed low intensity focused ultrasound to the stomach to reduce the inflammation of the region to see if that can improve ...

Gastric Focused Ultrasound Stimulation

The study is intended to assess feasibility and preliminary physiological effects and is not designed to establish clinical efficacy.

Efficacy of Gastric Electrical Stimulation for Gastroparesis

Conclusions: Comparing GES in US vs. Europe demonstrated significant differences in gastroparesis demographics and percentage of patients with GET data. After ...

Temporary Endoscopic Stimulation in Gastroparesis-like ...

Gastric electrical stimulation improves outcomes of patients with gastroparesis for up to 10 years.

Gastric Electrical Stimulation for Gastroparesis (HEAL Trial)

Research has shown that gastric electrical stimulation (GES) is generally safe for treating gastroparesis. Studies indicate that GES can help reduce symptoms

Efficacy of Gastric Electrical Stimulation for Gastroparesis

There was a statistical difference between the causes of gastroparesis in the patients receiving GES (P-value < 0.00001). There was also significant difference ...

Outcomes of High-Frequency Gastric Electric Stimulation for ...

Results: fourteen patients underwent implantation of gastric electrical stimulator without any postoperative complications.

Gastric electrical stimulation for gastroparesis: A goal greatly ...

Gastric electrical stimulation is safe and effective: a long-term study in patients with drug-refractory gastroparesis in three regional centers.