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Observational Study of Pyloric Sphincter Abnormalities in Gastroparesis

This study is looking at whether people with gastroparesis symptoms have problems with their pyloric sphincter (the muscle that controls food leaving the stomach). Researchers want to see how common these problems are using special tests like the Endoflip™ (which measures the size and flexibility of the sphincter), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using the Gastric Alimetry™ System. The main goal is to measure the flexibility of the pylorus at the beginning of the study. You might be able to join if you are between 18 and 85 years old and have symptoms of gastroparesis, whether it's related to diabetes or has no known cause. The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to include 150 participants. It will compare people with gastroparesis symptoms to those without.
What's involved
The study will assess your lower esophageal and pyloric sphincter using an Endoflip™ catheter, a water load satiety test, and the Gastric Alimetry™ System.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04661215

Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Recruiting
Not specifiedAges 18–85Observational
Johns Hopkins Bloomberg School of Public Health
~150 participants
Updated 2026-04-03 on ClinicalTrials.gov

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Distensibility of the pylorus
Measured over Baseline

Conditions

Gastroparesis
Idiopathic Gastric Motility Disorder
Diabetic Gastroparesis

Explore related trials

Gastrointestinal hypomotilityGastroparesis

Where it's being run

5 sites across 5 states
Arizona1
Kentucky1
Massachusetts1
North Carolina1
Pennsylvania1

Study leadership

  • Pankaj Pasricha, MD · STUDY_CHAIR · Mayo Clinic
  • Henry Parkman, MD · STUDY_CHAIR · Temple University

Who to contact

Laura A Miriel, BS
[email protected]
410-955-4165
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Ulcer of the esophagus, stomach, or duodenum
Esophageal varices 6. Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy. 7. Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc) 8. Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom 9. Acute or chronic renal insufficiency 10. Current eating disorders 11. Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures. 12. Individuals with contraindications for endoscopy, including bleeding abnormalities 13. Allergy to eggs preventing sedation with propofol and/or gastric emptying test 14. Significant dysphagia 15. Prior inflammatory bowel disease, Crohn's 16. History of any esophageal/gastric/pyloric injection of botulinum toxin 17. Patients on daily opioid use or \>3 day/week use 18. Use of glucagon-like peptide 1 (GLP1) receptor agonists or Sodium-Glucose Transport Protein 2 (SGLT2); Gastric inhibitory polypeptide (GIP)- glucagon-like peptide (GLP) combo

What this trial measures

  • Distensibility of the pylorusBaseline

    Distensibility of the pylorus will be calculated as the median of three measurements (not three different inflations) of distensibility (mm2/mmHg) of the pylorus pressure using the Endoflip balloon catheter at 50 mL volume