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Device
Capsule Endoscopy for Indigestion
N/A
Waitlist Available
Led By Lin Chang, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must meet one of the following categories: Gastroparesis, Functional Dyspepsia, G-POEM, Controls
Meets Rome IV diagnostic criteria for functional dyspepsia: Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis, No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations, Meet criteria for Epigastric pain syndrome and/or Postprandial distress syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will assess whether a magnetically controlled capsule endoscopy is a useful tool in diagnosing gastroparesis and functional dyspepsia.
Who is the study for?
This trial is for people with gastroparesis or functional dyspepsia, which are conditions that affect stomach motility and digestion. Participants must have documented delayed gastric emptying, experience specific digestive symptoms, and meet certain diagnostic criteria. They should not be on opioids or certain other medications recently, nor should they have had recent surgeries affecting the stomach or treatments that could interfere with results.Check my eligibility
What is being tested?
The study is testing a new method called magnetically controlled capsule endoscopy to see if it's useful in evaluating stomach movement disorders like gastroparesis and indigestion. This involves swallowing a small camera in a capsule that can be guided through the stomach using magnets.See study design
What are the potential side effects?
Potential side effects may include discomfort from swallowing the capsule, risk of capsule retention if there's an undiagnosed obstruction, mild abdominal pain or bloating after the procedure, and gagging during swallowing of the capsule.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with either gastroparesis, functional dyspepsia, or I am a control subject.
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I have been diagnosed with functional dyspepsia based on Rome IV criteria.
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I experience stomach pain or burning at least once a week.
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I feel uncomfortably full or quickly full when eating, at least 3 days a week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dyspepsia Severity Scale symptom ratings at baseline and during the study at timepoints with discomfort if present.
Frequency and direction of contractions
Largest diameter of the pylorus
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: GastroparesisExperimental Treatment1 Intervention
Patients with a diagnosis of gastroparesis meeting the inclusion criteria
Group II: G-POEMExperimental Treatment1 Intervention
Patients who received a G-POEM procedure meeting the inclusion criteria
Group III: Functional DyspepsiaExperimental Treatment1 Intervention
Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria
Group IV: ControlExperimental Treatment1 Intervention
No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,785 Total Patients Enrolled
Lin Chang, MDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
153 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrolment figure for this clinical trial?
"Affirmative. Clinicaltrials.gov attests that this trial is currently enlisting contributors; it was first posted on the 1st of December 2021 and last updated on the 9th of January 2023, with a recruitment goal of 17 people from one facility."
Answered by AI
Are there any opportunities to participate with this experiment?
"According to the information hosted on clinicaltrials.gov, this medical study is actively seeking out participants and has been since it was first posted in December 2021. The details of the trial were last updated on January 9th 2023."
Answered by AI
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