Gastroparesis Trial, Recruiting NCT04661215 Sponsor: Johns Hopkins Bloomberg School of Public Health Condition: Gastroparesis
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Gastroparesis Trial, Recruiting

NCT04661215
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

If you have gastroparesis symptoms:

  • You are willing and able to sign a consent form and take part in the full study
  • You are between 18 and 85 years old
  • You have symptoms of gastroparesis caused either by diabetes or by an unknown reason
  • Your gastroparesis symptoms score at least 2.0 on a standard symptom rating scale called the GCSI
  • You have already had a stomach-emptying scan (a 4-hour test using a small amount of radiation) done for your own medical care within the last 6 months — this scan is not part of the research itself
  • You are willing not to start any new treatments until the study procedures are finished
  • You are willing to stop certain medications (including antacids, stomach-motility drugs, opioid painkillers, anticholinergics, laxatives, proton pump inhibitors, cannabis products, and others) for 3 days before each visit
  • You are willing to avoid all food and water from midnight before each visit (at least 8 hours of fasting) until after the visit is done

If you are a healthy comparison (control) participant:

  • You are willing and able to sign a consent form
  • You are 18 years old or older
  • You are already scheduled for an upper stomach camera procedure (endoscopy) as part of your own medical care, for reasons such as diarrhea, GI bleeding, low iron levels, or preparation for weight-loss surgery
  • You do not have significant upper stomach symptoms (scoring no more than 1 on the GCSI symptom scale)

Who may not be able to join:

  • You have previously had surgery on your esophagus or stomach, including a procedure called Nissen fundoplication
  • You have previously had surgery or a procedure on the valve between your stomach and small intestine (the pylorus)
  • You have a known history of a swallowing disorder called achalasia, or a narrowing of the esophagus
  • You have a known blockage or obstruction anywhere in your digestive tract
  • A previous stomach camera procedure found ulcers in your esophagus, stomach, or upper small intestine, or enlarged veins in your esophagus (varices)
  • You have severe lung disease or a large amount of food stuck in your stomach, which could make the procedure more complicated
  • You have significant disease or damage in your stomach or upper small intestine that could affect how your stomach moves
  • You have another long-term illness that could be causing your digestive symptoms (confirm with trial site)
  • You have kidney problems, either short-term or long-term
  • You currently have an eating disorder
  • You are pregnant (a urine pregnancy test will be done before the procedure for all women)
  • You have any condition that makes it unsafe for you to have a stomach camera procedure, including problems with blood clotting
  • You are allergic to eggs, which would prevent the use of a common sedation medication (propofol) and may affect the stomach-emptying test
  • You have significant difficulty swallowing
  • You have a history of inflammatory bowel disease or Crohn's disease
  • You have ever had botulinum toxin (Botox) injected into your esophagus, stomach, or pylorus
  • You take opioid painkillers every day, or more than 3 days per week
  • You currently take certain diabetes or blood sugar medications, including GLP-1 receptor agonists (such as semaglutide), SGLT2 inhibitors, or GIP/GLP combination drugs

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Pankaj Pasricha, MD, Mayo Clinic

Phone: 410-955-4165

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Johns Hopkins Bloomberg School of Public Health
Registry
ClinicalTrials.gov
Start date
13 January 2026
Est. completion
30 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Distensibility of the pylorus

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov