Focused Ultrasound Stimulation for Gastroparesis
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo two study visits in a randomized crossover design, receiving either active gastric focused ultrasound stimulation or sham stimulation.
Follow-up
Participants are monitored for changes in gastric electrical activity and gastrointestinal symptoms after each treatment session.
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
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.
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.
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 ...
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helda.helsinki.fi
helda.helsinki.fi/server/api/core/bitstreams/75000dcb-caa8-42eb-a543-99b5209fbeed/contentOutcomes 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.
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